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Navitus is committed to providing high quality services to its members and, as part of this commitment, strives to protect member safety. We have created policies and procedures in the event of drug recalls or situations that pose a threat to the health and safety of our members. We monitor these situations closely and follow the guidelines of the U.S. Food and Drug Administration (FDA).

Read about the drug recall process

Recent drug recalls include:
Date:
Jun 21, 2022
Recall:
CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor
Details:

June 21, 2022 - Smyrna, TN, Vi-Jon, LLC is voluntarily recalling 1 (one) lot of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) to the consumer level. Testing identified the affected lot of the product to contain the bacteria Gluconacetobacter liquefaciens.

Risk Statement: Immunocompromised patients, who consume this product, may be at increased risk for invasive infections caused by Gluconacetobacter liquefaciens that could lead to serious, life threatening adverse health consequences. To date, Vi-Jon, LLC has not received any complaints related to this recall.

The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in 1/2 to 6 hours. The product is packaged in a 10 oz clear round plastic bottle. The affected CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor lot includes the following batch number: 0556808 and expiration date: 12/2023 on the shoulder of the bottle. This lot of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor was sent to a 3rd Party Outside Lab for testing per CVS request as a first production sample for CVS. This lot of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor was distributed Nationwide at CVS drug store locations.

Vi-Jon, LLC has already notified CVS by phone and email and is arranging for return of all recalled product.

Consumers that have this recalled product should stop using and return any remaining product to the place of purchase.

Consumers with questions regarding this recall can contact Vi-Jon, LLC by e-mail Recalls@Vijon.com Monday-Friday, from 7:30 am to 4:30 pm Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

FDA Link:
Read more info at FDA.gov
Date:
May 23, 2022
Recall:
Anagrelide Capsules, USP 0.5 mg
Details:

Parsippany, NJ. Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of a single lot of Anagrelide Capsules, USP 0.5 mg (Lot number GD01090), to the consumer level in the United States. This voluntary recall was initiated due to dissolution test failure detected during routine stability testing. No other lots are impacted.

Administration of this product with lower dissolution – taking longer to dissolve once ingested -- may result in decreased effectiveness or ineffectiveness of the drug to exert its platelet-reducing effect. Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body. For seriously ill patients with elevated platelet counts, less available anagrelide in the body could increase the risk of clotting (blood coagulation), and clotting or bleeding events such as a heart attack or stroke, which could be life threatening. To date, Teva has not received any product quality complaints or adverse event reports, of this nature, for the recalled lot.

Anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. Information about the affected lot is listed in the table below. It is packed in bottles with 100 Capsules. Teva distributed 4224 bottles nationwide from 07-30-2020 through 09-02-2020 to its wholesale, distributor and retail customers under the label for Teva Pharmaceuticals USA, Inc.

NDC Lot # Exp. Date
0172-5241-60 GD01090 05/2022


Teva notified its customers on May 11, 2022, alerting them that the lot was recalled and requesting that they return impacted product. Instructions for returning recalled product and receiving a credit are given in the customer recall letter (Anagrelide Recall 05 2022 Direct Accounts Letter Consumer Level 20 MAY 2022.pdf) External Link Disclaimer and consumer recall letter (Anagrelide Recall 05 2022 _Patient Letter 20 MAY 2022.pdf External Link Disclaimerreleased by Teva.

FDA Link:
Read more info at FDA.gov
Date:
Apr 22, 2022
Recall:
ACCUPRIL® (Quinapril HCl)
Details:

FOR IMMEDIATE RELEASE - NEW YORK, NY., April 22,2022.

Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Accupril is indicated for the treatment of hypertension, to lower blood pressure.  Accupril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. Accupril has a safety profile that has been established over 30 years. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables below and photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022.

Accupril® (Quinapril HCl Tablets), 10 mg
Accupril® (Quinapril HCl Tablets), 20 mg
Accupril® (Quinapril HCl Tablets), 40 mg
 

NDC

Lot Number

Expiration
Date

Strength

Configuration/
Count

0071-0530-23 DR9639 2023 MAR 31 10 mg 1 x 90 count bottle
0071-0532-23 DX8682 2023 MAR 31 20 mg 1 x 90 count bottle
DG1188 2022 MAY 31 20 mg 1 x 90 count bottle
0071-0535-23 DX6031 2023 MAR 31 40 mg 1 x 90 count bottle
CK6260 2022 MAY 31 40 mg 1 x 90 count bottle

 

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.

If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Please request they immediately cease distribution of the affected product and promptly contact Sedgwick at 888-345-0481 (Mon.-Fri. 8:00 am - 5:00 pm ET) to obtain a Business Reply Form (BRF) to initiate the return process.

If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately against the table above. If you have any of the affected product lots in your inventory, please follow the instructions above for returning the product to Sedgwick. Additionally, if you are aware of any patients to whom you dispensed the affected lots who still may have the product in their possession, please ask them to return the product to you and then follow the instructions above for returning the product to Sedgwick. To request replacement product for any Pfizer PAP or Pfizer IPAP product you return, please contact 833-203-2776 (Mon.-Fri. 8 am-6 pm ET).

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Patients with the affected product should contact Sedgwick at 888-345-0481 (Mon.-Fri. 8:00 am - 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.​

FDA Link:
Read more info at FDA.gov
Date:
Apr 12, 2022
Recall:
Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100)
Details:

Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Nationwide Recall of One Batch of Insulin Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargine- yfgn) Injection, 100 units/mL (U-100), which is packaged in a 10 mL vial that is inside a carton. This product is not the branded Semglee vial but the unbranded Insulin Glargine- yfgn vial. This batch is being recalled due to the potential for the label to be missing on some vials. The product information, batch number and expiry date information are present on the carton.

This batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the US between December 9, 2021, and March 4, 2022. The recalled batch is as follows:

NDC # Name and Strength Size Batch# Expiry
49502-393-80 Insulin Glargine (Insulin glargine-yfgn)
Injection, 100 units/mL (U-100)
10 mL vial BF21002800 Aug 2023
 

Risk Statement: For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine vials could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no adverse events related to this recall have been received for this product.

This recall does not pertain to the branded interchangeable biosimilar, Semglee® (insulin glargine-yfgn) injection but to the unbranded interchangeable biosimilar Insulin Glargine-yfgn vial.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

The company has initiated the recall of batch BF21002800 and notified its distributors and retailers by letter and is arranging for return of all recalled products. Following are actions for wholesalers, retailers and consumers:

  • Wholesaler: Immediately examine your inventory, quarantine, and discontinue distribution of the batch subject to recall. In addition, if you have further distributed the product, please identify all customers, including retail level customers, and provide a list of customers via Microsoft excel file to mylan5889@sedgwick.com within 5 business days. Sedgwick (Stericycle) will notify your retail level customers that received the affected batch.
  • Retailer: Immediately examine your inventory, quarantine, and discontinue distribution of this batch.
  • Consumer: If you have an unlabeled product, please contact Stericycle at 1-888-912-7084 for the documentation packet to return product to Stericycle.

Consumers with questions regarding this recall can contact Viatris Customer Relations by 1-800-796-9526 or customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.​

FDA Link:
Read more info at FDA.gov
Date:
Mar 29, 2022
Recall:
Arubicin Hydrochloride Injection USP 5 mg/5 mL vial
Details:

Teva Pharmaceuticals has initiated a voluntary nationwide recall of lot 31329657B of IDArubicin Hydrochloride Injection USP 5 mg/5 mL vial, to the user level in the United States. This voluntary recall is initiated based on an internal inspection that found particulate matter in one vial of the product identified as silica and iron oxide. No other vials have been observed to contain this defect. To date, Teva has received no product quality complaints or adverse event reports of this nature for the subject recall lot.

The administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. While the health hazard risk could be severe if particulate matter is infused, Teva’s internal health assessment determined that the likelihood of patient harm is remote or unlikely

IDArubicin Hydrochloride Injection USP in combination with other approved anti-leukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. Information about the affected product is listed in the table below. It is packed in 5 mL Single Dose Vials. Teva distributed 1,565 vials Nationwide from 12-04-2020 through 08-18-2021 to 4 of its Wholesale customers under the label for Teva Pharmaceuticals USA, Inc.

Vial/Carton NDC Lot # Exp. Date
0703-4154-11 31329657B 08/2023


Teva notified its customers on March 28, 2022 and asked that the lot be recalled and to make arrangements for impacted product to be returned. Instructions for returning recalled product and crediting are given in the recall letter released by Teva.​

FDA Link:
Read more info at FDA.gov
Date:
Mar 21, 2022
Recall:
Orphenadrine Citrate 100 mg Extended Release (ER) Tablets
Details:

Princeton, NJ, Sandoz Inc. (“Sandoz”) is initiating a voluntary recall of 13 lots (listed below) of oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets to the consumer level. The presence of a nitrosamine (N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine (NMOA or Nitroso-Orphenadrine)) impurity, which has the potential to be above the U.S. Food and Drug Administration (FDA)’s Acceptable Daily Intake (ADI) limit of 26.5 ng/day, was detected in the lots during recent testing. These 13 lots of Orphenadrine Citrate ER Tablets were shipped to customers from August 2019 to April 2021.

Nitrosamines are substances with carcinogenic potency (substances that could cause cancer) when present above the allowable exposure limits. While the use of product belonging to the recalled lots may represent a risk to patients, to date, Sandoz has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot.

Orphenadrine Citrate ER Tablets are used as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The product is packaged in 100-count and 1000-count bottles and was distributed nationwide in the USA to wholesalers and distributors.

Product Name NDC Number Lot Number Expiration Date Date of Manufacture
Orphenadrine Citrate ER Tablets 0185-0022-01 JX6411 05/2022 5/24/2019
Orphenadrine Citrate ER Tablets 0185-0022-01 JX6413 05/2022 5/24/2019
Orphenadrine Citrate ER Tablets 0185-0022-01 KC0723 08/2022 8/21/2019
Orphenadrine Citrate ER Tablets 0185-0022-01 KC3303 08/2022 8/21/2019
Orphenadrine Citrate ER Tablets 0185-0022-01     KE4348 11/2022 11/6/2019
Orphenadrine Citrate ER Tablets 0185-0022-01 KE7169 11/2022 11/6/2019
Orphenadrine Citrate ER Tablets 0185-0022-01 KE4349 11/2022 11/6/2019
Orphenadrine Citrate ER Tablets 0185-0022-01 KL3199 03/2023 3/3/2020
Orphenadrine Citrate ER Tablets 0185-0022-01 KM0072 03/2023 3/3/2020
Orphenadrine Citrate ER Tablets 0815-022-10   KS3939+ 03/2023 3/3/2020
Orphenadrine Citrate ER Tablets 0185-0022-01 LA7704 10/2023 10/6/2020
Orphenadrine Citrate ER Tablets 0185-0022-01 LA7703 10/2023 10/6/2020
Orphenadrine Citrate ER Tablets 0185-0022-01 LA9243 11/2023 11/18/2020

+ 1,000-count bottle

This recall of Orphenadrine Citrate ER Tablets is specific to the lots listed above and does not apply to any other strengths of Sandoz Orphenadrine Citrate ER Tablets nor to other lot numbers of the product. Any product returned that is not associated with this recall will be destroyed, and no credit will be issued.

Sandoz is notifying its wholesalers and distributors by mail and is arranging for the return of all recalled product. Wholesalers and distributors that have Orphenadrine Citrate ER Tablets subject to this recall should immediately stop distribution of the recalled product and quarantine and return all recalled product in their inventory.

Consumers who have Orphenadrine Citrate ER Tablets being recalled should stop taking the recalled product and immediately consult with their physician to obtain another prescription. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.​

FDA Link:
Read more info at FDA.gov
Date:
Mar 21, 2022
Recall:
SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes
Details:

San Diego, March 21, 2022 – Adamis Pharmaceuticals Corporation External Link Disclaimer (Nasdaq: ADMP) is voluntarily recalling certain lots of SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes to the consumer level. The batches in the table below are being recalled due to the potential clogging of the needle preventing the dispensing of epinephrine. US WorldMeds (USWM) exclusively markets and distributes SYMJEPI in the United States, under license from Adamis, the NDA holder. USWM will handle the entire recall process for Adamis, with Adamis oversight. SYMJEPI is manufactured and tested for Adamis by Catalent Belgium S.A.

Risk Statement:

If a person is experiencing an allergic reaction and/or anaphylaxis and is unable to access life-saving epinephrine due to the syringe malfunction, it can lead to life threatening consequences including death. Although not confirmed to be related to the recall, there have been two different customer complaints on three syringes, regarding difficulty in dispensing the product, to date. However, neither US WorldMeds nor Adamis Pharmaceuticals has received, or is aware of, any adverse events related to this recall.

The recall encompasses all of the following batches, within expiry:

Product

Strength

NDC

Lot

Expiration

SYMJEPI (epinephrine) Injection 0.15 mg/0.3 mL 78670-131-02 21101Y 11/30/2022
0.3 mg/0.3 mL 78670-130-02 21041W 8/31/2022
21081W 11/30/2022
21102W 2/28/2023

SYMJEPI is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets, and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

The products are packaged in 2-count Pre-Filled Single-Dose Syringes per carton and were distributed nationwide in the USA and directly to customers and/or medical facilities. The products can be identified by the label containing the US WorldMeds name and logo pictured on the cartons below.

US WorldMeds is notifying its customers by email, FDA alerts, and direct outreach. Consumers and institutions that have products that are subject to this recall should stop using the products immediately and may either return or discard the recalled lots. Consumers with questions regarding this recall can call (888) 900-8796 or e-mail questions at medinfo@usworldmeds.com Monday-Friday from 8:00 am to 4:00 pm ET.​

FDA Link:
Read more info at FDA.gov
Date:
Jan 26, 2022
Recall:
Polymyxin B for Injection USP, 500,000 Unit per Vial
Details:

January 26, 2022 – East Windsor, New Jersey, AuroMedics Pharma LLC has initiated a voluntary recall of lot number CPB200013 of Polymyxin B for Injection USP, 500,000 Units/Vial, to the consumer level from the USA market due to a product complaint for the presence of particulate matter, identified as hair being discovered in a vial within this lot.

Risk Statement: The administration of an intravenous product containing hair, even with the use of a filter, could cause a patient to experience serious hypersensitivity reactions that may be life- threatening. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from this lot.

Polymyxin B for Injection USP is a sterile, white lyophilized cake or powder, suitable for preparation of sterile solutions for intramuscular, intravenous, intrathecal, or ophthalmic use indicated in the treatment of infections or the urinary tract, meninges (membranes that protect the brain and spinal cord), and bloodstream caused by susceptible strains of bacteria. It is packaged in a carton containing vials for Parenteral or Ophthalmic Administration, NDC 55150-234-10. The affected Polymyxin B for Injection lot being recalled is CPB200013 with an expiration date of 09/2022. AuroMedics shipped the entire lot to wholesalers nationwide from March 19, 2021, through June 14, 2021.

The product label is as shown below:

AuroMedics Pharma LLC is notifying its distributors by recall letters and is arranging for return/replacement of all recalled product. Consumers/distributors/retailers that have the product lot which is being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate.

Consumers with medical questions regarding this recall or to report an adverse event can contact AuroMedics Pharma LLC, from 8:00 am to 5:00 pm M-F EST at:

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.​

FDA Link:
Read more info at FDA.gov
Date:
Jan 18, 2022
Recall:
Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens
Details:

Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential for the label to be missing on some prefilled pens within a labelled carton for this particular batch.

This batch was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty L.P. in the U.S. between May 11, 2021 and November 11, 2021. The recalled lot is as follows:
 

NDC # Name and Strength Size Batch# Expiry
49502-196-75 Semglee® (insulin glargine injection),
100 units/mL (U-100)
3mL Prefilled Pen BF20003118 August 2022


Risk Statement: A missing label on Semglee® (insulin glargine) prefilled pens, for patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), could lead to a mix-up of products/strengths, resulting in administration of the wrong insulin. Administration of the wrong insulin could result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, the company has not received any reports of adverse events related to this recall.

This recall does not pertain to the recently launched interchangeable biosimilars, Semglee® (insulin glargine-yfgn) injection, a branded product, or Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus and is packaged in prefilled pens in cartons of five (5) pens. The recalled product can be identified by prefilled pens missing a white label with the product name and dosage information affixed around the pen.

The company has initiated the recall of batch BF20003118 and notified its distributors and retailers by letter and is arranging for return of all recalled products. Following are actions for wholesalers, retailers and consumers:

  • Wholesaler: Immediately examine your inventory, quarantine, and discontinue distribution of this lot. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to mylan6069@sedgwick.com within 10 business days. Stericycle will notify your retail level customers that received the affected batch.
  • Retailer: Immediately examine your inventory, quarantine, and discontinue distribution of this batch.
  • Consumer: If you have an unlabeled product, please contact Stericycle at 1-888-843-0255 for the documentation packet to return product to Stericycle.

Consumers with questions regarding this recall can contact Viatris Customer Relations by 800-796-9526 or customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.​

FDA Link:
Read more info at FDA.gov
Date:
Jan 7, 2022
Recall:
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg
Details:

01/07/2022 – Cranford, New Jersey, Viona Pharmaceuticals Inc., is voluntarily recalling twenty-three (23) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg at the consumer level. The reason for the recall is an Out of Specification (OOS) result observed for one lot of the product (M008132) “N-nitrosodimethylamine (NDMA) (By GC- MS/MS)” test at 17 Month(s), 25°C/60%RH Long-term stability samples. In an abundance of caution, the firm has decided to voluntarily recall 23 batches which we have determined having a valid shelf life within the US market. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India for U.S. distribution by Viona Pharmaceuticals Inc.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Patients who have received impacted lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. According to the FDA, it could be dangerous for patients with this serious condition to stop taking their Metformin without first talking to their healthcare professionals. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press- announcements-ndma-metformin. To date, neither Viona Pharmaceuticals Inc., nor Cadila Healthcare Limited have received any reports of adverse events related to this recall.

The product is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 72578-036-01. The recalled lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are listed in the below table. The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with "Z", "C" on one side and "20" on the other side. Metformin Hydrochloride Extended-Release Tablets, USP 750 mg was distributed Nationwide to Distributors.

Product Name: Metformin Hydrochloride Extended‐Release Tablets, USP 750 mg
NDC: 72578‐036‐01
Sr. No. Batch No. Exp. Date
1. M008130 06/2022
2. M008131 06/2022
3. M008132 06/2022
4. M008133 06/2022
5. M010080 07/2022
6. M010081 07/2022
7. M011029 08/2022
8. M011030 08/2022
9. M011031 08/2022
10. M011032 08/2022
11. M011304 08/2022
12. M013394 09/2022
13. M013395 09/2022
14. M013396 09/2022
15. M013966 09/2022
16. M013967 09/2022
17. M100831 12/2022
18. M100832 12/2022
19. M100833 01/2023
20. M100834 01/2023
21. M101267 01/2023
22. M102718 01/2023
23. M102719 01/2023


Viona Pharmaceuticals Inc., is notifying its customers by email and mail (FedEx Overnight) and is arranging for the return of all recalled products to our recall processor at the following address

Inmar Pharmaceuticals Services-Recalls
3845 Grand Lakes Way,
Grand Prairie, Texas 75050

Consumers with questions regarding this recall can contact our recall processor Inmar Pharmaceutical Services by phone at 1-855-249-3303, option 1; Monday – Friday (excluding holidays), 9:00 am – 5:00 pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.​

 

FDA Link:
Read more info at FDA.gov
Date:
Dec 28, 2021
Recall:
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg
Details:


12/28/2021 – Cranford, New Jersey, Viona Pharmaceuticals Inc., is voluntarily recalling thirty three (33) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. Reason for the recall is an Out of specification result observed for the said product, Lot number M008132, “N-nitrosodimethylamine (NDMA) (By GC-MS/MS)” test at 17 Month(s), 25°C/60%RH Long-term stability samples. As a precautionary measure firm voluntarily recall all the marketed 33 batches having valid shelf life. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India for U.S. distribution by Viona Pharmaceuticals Inc.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Patients who have received impacted lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. According to the FDA, it could be dangerous for patients with this serious condition to stop taking their Metformin without first talking to their healthcare professionals. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin. To date, neither Viona Pharmaceuticals Inc., nor Cadila Healthcare Limited have received any reports of adverse events related to this recall.

The product is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 72578-036-01. Firm recalled Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are listed in the below table. The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with "Z", "C" on one side and "20" on the other side. Metformin Hydrochloride Extended-Release Tablets, USP 750 mg was distributed Nationwide to Distributors.

Product Name: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg
NDC: 72578-036-01

Sr. No. Batch No. Exp. Date
1. M008130 06/2022
2. M008131 06/2022
3. M008132 06/2022
4. M008133 06/2022
5. M010080 07/2022
6. M010081 07/2022
7. M011029 08/2022
8. M011030 08/2022
9.        M011031 08/2022
10.    M011032 08/2022
11.    M011304 08/2022
12.    M013394 09/2022
13.    M013395 09/2022
14.    M013396 09/2022
15.    M013966 09/2022
16.    M013967 09/2022
17.    M100831 12/2022
18.    M100832 12/2022
19.    M100833 01/2023
20.    M100834 01/2023
21.    M101267 01/2023
22.    M102718 01/2023
23.    M102719 01/2023
24.    M102720 01/2023
25.    M102721 02/2023
26.    M102722 02/2023
27.    M104172 02/2023
28.    M104173 02/2023
29.    M104174 02/2023
30.    M104175 02/2023
31.    M104176 02/2023
32.    M105889 03/2023
33.    M105890 03/2023

Viona Pharmaceuticals Inc., is notifying its customers by email and mail (FedEx Overnight) and is arranging for return of all recalled products to our recall processor at the following address

Eversana Life Science Services
c/o Viona recall
ATTN: Returns Department
4580 S. Mendenhall Rd.
Memphis, TN 38141

Consumers with questions regarding this recall can contact our recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday – Friday, 8:00 am – 7:00 pm CDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.​
FDA Link:
Read more info at FDA.gov
Date:
Dec 27, 2021
Recall:
Nitroglycerin Lingual Spray
Details:

Padagis US LLC announced today it has issued a voluntary nationwide recall to the consumer/user level of the lots of Nitroglycerin Lingual Spray listed in the table below. Out of an abundance of caution, this product is being recalled from the market due to a complaint received that a unit may not dispense. There is a remote risk that the product may not properly dispense medication to patients in the event of a malfunction of their dispensing unit. This recall applies only to the 12g spray bottle and not the 4.9g spray bottle of this medication.

Drug NDC Strength Net Contents Lot # Expiration
Nitroglycerin
Lingual Spray
45802-210-02 400 mcg per
spray
12 g 150892 Oct 2022
153199 Feb 2023
156041 Apr 2023

 
Risk Statement: If the product does not deliver the appropriate amount of nitroglycerin, the patient will likely continue to experience chest pain. The label advises that if relief is not obtained after 3 doses over 15 minutes the patient should promptly seek medical attention. To date, Padagis has not received any reports of adverse events related to this recall.

Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of chest pain due to coronary artery disease in adult patients. All packaging and branding on affected units is that of Perrigo Company PLC. The product is packaged in a 12 g bottle contained within a carton. The medication was distributed Nationwide in the USA to wholesalers and retailers.​

FDA Link:
Read more info at FDA.gov
Date:
Dec 27, 2021
Recall:
Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes
Details:

Hawthorne, NY, December 27, 2021 ─ Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes, to the consumer level. This recall ONLY applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022”. No other lots of this product are impacted. Lot AC13786 is being recalled due to the presence of Ralstonia pickettii bacteria (“R. pickettii”), which was discovered by the manufacturer through routine testing.

R. pickettii is present in the natural environment (soil, water) and for healthy individuals with intact skin, is unlikely to cause any localized or systemic infections. However, for individuals who are immunocompromised, or whose skin is not intact (i.e. sunburn, psoriasis, abrasions), there is a reasonable possibility that systemic infections may occur if the product is contaminated with R. pickettii due to the presence of the corticosteroid component which enhances absorption of the ointment. If this bacterium is circulating in the human blood stream it can cause life-threatening, invasive infections such sepsis, pneumonia, meningitis, inflammation of the bone or bone marrow, and infection in the joint fluid and joint tissues. To date, Taro has not received any adverse event reports related to this lot.

The one (1) lot being recalled is as follows:

Lot # Amount Expiration Date
AC13786 96 units December 2022

Clobetasol Propionate Ointment USP, 0.05% is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses and is packaged in 60 g aluminum tubes with polypropylene puncture-tip caps. Each 60 g tube is labeled to indicate the name of the product, Clobetasol Propionate Ointment USP, 0.05% and the NDC # 51672-1259-3 (see image of container label below). The Lot Number and Expiration Date are displayed on the bottom of each tube and the end flap of the product carton.

Ninety-six (96) units of Lot AC13786 were distributed to two wholesale distributors in the U.S. market between November 16 and December 6, 2021. These two wholesale distributors may have further distributed this lot to their retail customers for prescription dispensing to patients who were prescribed Clobetasol Propionate Ointment USP, 0.05%, 60 g.

Taro has notified the affected distributors by phone, e-mail, and letters via U.S. Mail and is arranging for return of any containers of Clobetasol Propionate Ointment USP, 0.05%, 60 g, Lot AC13786 (expiration date of December 2022). Retail customers that have any quantities of Lot AC13786 which is being recalled, should stop distribution and return any unsold units to their wholesaler.

Consumers with questions regarding this recall can contact Taro by calling 1-866-923-4914 or by e-mail at TaroPVUS@taro.com, Monday through Friday between 7:00 am and 7:00 pm, U.S. Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
 
FDA Link:
Read more info at FDA.gov
Date:
Dec 8, 2021
Recall:
Lidocaine HCl Topical Solution USP, 4% by Teligent Pharma: Recall - Due to Super Potency
Details:

Teligent Pharma is recalling two lots of Lidocaine HCl Topical Solution USP, 4% - 50 mL because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 9-month (Lot 16345) and 18-month (Lot 15594) stability timepoint.

Use of the super potent product would result in a higher than intended lidocaine dose above that intended. An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient. Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly. If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result. Adults and the elderly who are more likely to use this product as well as children of lower body weight are more likely to experience local anesthetic systemic toxicity if a higher than intended lidocaine concentration is administered.

To date, Teligent Pharma has not received any reports of adverse events related to this recall.​

FDA Link:
Read more info at FDA.gov
Date:
Dec 1, 2021
Recall:
Sandoz, Inc. Issues Nationwide Recall of One Lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL Due to Temperature Excursion During Shipping
Details:


December 1, 2021 – Princeton, NJ, Sandoz Inc. (“Sandoz”) is initiating a recall of one lot (SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes to the consumer level. A portion of lot SAB06761A experienced a temperature excursion during shipment. Enoxaparin Sodium for Injection Lot SAB06761A was shipped to customers in the months of September and October 2021.

The exposure to higher temperatures may have significantly impacted the recalled product’s (lot SAB06761A) effectiveness and thus there may be reasonable probability of risk for patients with health conditions that the product is intended to treat. Such patients could be at risk for blood clots blocking blood vessels, an artery, or traveling to other tissues or organs causing pain, swelling, stroke, clots to the lung or death as a result of the underlying condition. To date, Sandoz has not received any reports of adverse events or injuries related to this recall.

The product is used for prevention of deep vein thrombosis (DVT) a condition that occurs when a blood clot forms in a deep vein, usually in the legs that can occur after surgeries or in patients with restricted mobility during illness; or prevention of complications associated with heart attacks. The product is packaged in cartons containing ten 0.4 mL syringes, NDC 0781-3246-64. Enoxaparin Sodium Injection was distributed Nationwide in the USA to wholesalers and retailers.

Product Name NDC Number Lot
Number
Expiration
Date
Date of
Manufacture
Enoxaparin Sodium
Injection, USP 40
mg/0.4 mL
00781-3246-64 SAB06761A 04/2023 05/26/2021


Please note: this recall is specific to only one batch (SAB06761A) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL and does not apply to any other strengths of Sandoz Enoxaparin Sodium Injection, USP or to other lots of the 40 mg/0.4 mL SKU.

Any product returned that is not associated with this recall will be destroyed and no credit issued.

Sandoz has already notified its wholesalers and retailers by mail and is arranging for return of all recalled product.

Consumers who have Enoxaparin Sodium Injection, USP 40 mg/0.4 mL (NDC 00781-3246-64 and Lot number SAB06761A) which is being recalled, should stop taking the recalled product, immediately consult with their physician to attain another prescription, and return the product where originally purchased. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.​

FDA Link:
Read more info at FDA.gov
Date:
Nov 19, 2021
Recall:
Levetiracetam Injection, USP
Details:

CHICAGO, IL – November 19, 2021 - Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of four lots of Levetiracetam Injection, USP, to the user level. The lack of container closure integrity, found in reserve sample vials may result in a non-sterile product.

Risk Statement: Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life threatening.  To date, Sagent has not received reports of any product complaints or adverse events associated with this issue.

Levetiracetam Injection, USP 500 mg per 5 mL, is used in the treatment of certain types of seizures and is packaged in a 5mL single-does vial. The Levetiracetam Injection, USP, label and affected lot numbers with Expiration Dates and NDC number can be found in the table below.  Product was distributed Nationwide from March to November  2021.

Product

Lot
Number

    Expiration Date    

    NDC Number    

    Distribution Dates    

 Levetiracetam Injection, USP B0G85VB     Jun-2022     25021-
    780-05
    May 2021 -
    August 2021
B0K88VA     Sep-2022     March 2021 -
    November 2021
B0K89VA     Sep-2022     August 2021 -
    November 2021
B1G194A     Jun-2023     October 2021 

Sagent Pharmaceuticals, Inc.  is notifying customers by fax, email, FedEx, and/or certified mail, which includes arrangements for return of all recalled product. Customers that have Levetiracetam Injection, USP 500mg per 5 mL, which is being recalled, have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return as directed the recalled lots of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. Healthcare/distributors/retailers that have product which is being recalled should stop using product and return the recalled product. The necessary form to document product information, as well as other information regarding this recall, is available at www.Sagentpharma.com External Link Disclaimer.

Consumers or healthcare workers with any questions regarding this recall can contact the customer call center (866) 625-1618 M-F, 8am-7pm CST. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

FDA Link:
Read more info at FDA.gov
Date:
Oct 27, 2021
Recall:
Monject Flush Prefilled Saline Syringes
Details:
On August 19, 2021, Aligned Medical Solutions initiated a nationwide recall of Cardinal Health’s Monoject™ Flush Prefilled Saline Syringes placed into 9,378 kits. Including;
  • 1 lot of AMS-9041CP Leaderflex Insertion Kit with Ultrasound
  • 1 lot of AMS-9046CP-1 Insertion Tray-RX
  • 45 lots of AMS8939A Universal Procedure Pack w/Split Drape
  • 1 lot of AMS9957A Port Insertion Pack
  • 3 lots of AMS12149 Procedure Pack
These convenience kits have been found to contain the Cardinal Health’s Monoject™ Flush Prefilled Saline Syringe part # 8881570121, which has been recalled for the potential for the plunger to draw back after the air has been expelled and reintroduced air back into the syringe. If a clinician is not aware of air being introduced into the syringe, the clinician could inadvertently push air into the vascular system creating the potential for an air embolism. Injection of air into the vascular system can cause air embolism which can result in serious adverse health consequences or death.

See Cardinal Health’s Urgent Medical Device Recall Event 2021-04063 Monoject™ Flush Prefilled Saline Syringes https://www.cardinalhealth.com/en/cmp/ext/corp/monoject-flush-prefilled-saline-syringes-issue.htmlExternal Link Disclaimer

Consumers who have affected product(s) should immediately review their inventory and quarantine all affected kits. Contact the Quality Department for further instructions on labeling and replacement product if needed at 407-638-9924. Customers will be provided with a yellow label that is to be placed on the packs containing the recalled Cardinal Health’s Monoject™ Flush Prefilled Saline Syringe. The label will read as follows;
  1. At the time the kit is opened for use the prefilled syringe manufactured by Cardinal Health should be identified, set aside and not used. Do not use the prefilled syringe in the kit.
  2. The recalled prefilled syringe should be rendered unusable to protect against inadvertent use and disposed or pursuant to the medical waste policies in effect at your institution
Consumers can request replacement syringes by calling 407-638-9924.

Recalled Product(s) were manufactured from 01/13/2020 to 10/14/2020 and distributed from 01/23/2020 to 10/19/2020.
FDA Link:
Read more info at FDA.gov
Date:
Oct 19, 2021
Recall:
Merck Issues Voluntary Nationwide Recall of CUBICIN® (Daptomycin for Injection) 500 mg, Lot 934778
Details:
Merck (NYSE: MRK), known as MSD outside the United States and Canada, is voluntarily recalling one lot of CUBICIN® (daptomycin for injection) 500mg for intravenous use, Lot 934778, Exp June 2022. Because treatment with CUBICIN is likely to be initiated at a hospital or other monitored healthcare setting, the recall is being conducted to the user level, including hospital and administering institutions. Approximately 22,000 vials are affected by this recall. The recall has been initiated following receipt of a customer complaint reporting that a piece of glass was found in a vial of CUBICIN after reconstitution. 

Intravenous infusion of glass particulates has the potential to cause serious health consequences if the particulate is small enough to be withdrawn from the vial and infused into the patient. Local irritation or swelling at the infusion site may occur in response to the presence of foreign material. More serious potential outcomes include blockage and clotting in blood vessels, which can be life-threatening if a critical organ is affected. Other clinical consequences could include prolonged hospitalization, particularly in those patients receiving an extended treatment regimen for which multiple vials of CUBICIN are administered over the course of treatment. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter prior to administration. To date, Merck has not received any reports of adverse events related to this recall.
FDA Link:
Read more info at FDA.gov
Date:
Oct 14, 2021
Recall:
Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets
Details:
Baltimore, Maryland, October 14, 2021: Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan. Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US.

Lupin discontinued the marketing of Irbesartan and Irbesartan and HCTZ tabs in Jan 2021.

Risk Statement: N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

From October 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches), to September 30, 2021, Lupin received 4 reports of illness from Irbesartan and 0 reports from Irbesartan and Hydrochlorothiazide.

Irbesartan tablet USP is an angiotensin II receptor blocker indicated for treatment of hypertension, to lower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. Irbesartan Tablets USP 75mg, 150mg and 300mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan Tablets on Jan 7, 2021.​​

Irbesartan and hydrochlorothiazide tablet USP is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Irbesartan and hydrochlorothiazide tablet USP, 150mg/12.5mg and 300mg/12.5mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan and HCTZ Tablets on Jan 7, 2021
FDA Link:
Read more info at FDA.gov
Date:
Oct 12, 2021
Recall:
Lidocaine HCl Topical Solution
Details:
Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling the five lots of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle listed in the table below to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint.

Risk Statement: Use of the super potent product would result in a higher than intended lidocaine dose above that intended. An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient. Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly. If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result. Adults and the elderly who are more likely to use this product as well as children of lower body weight are more likely to experience local anesthetic systemic toxicity if a higher than intended lidocaine concentration is administered. To date, Teligent Pharma, Inc. has not received any reports of adverse events related to this recall.


The product is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract and is packaged in a 50ml glass bottle with a screw cap with the identification NDC# 52565-009-50 and 63739-997-64. The product can be identified by the following labeling: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL). Product was distributed at the wholesale and retail distribution levels in the US and Canada.
 
Product NDC Lot Number Expiration
Lidocaine Hydrochloride Topical Solution 
USP 4% (40 mg/mL), 50 mL bottle
52565-009-50 13262 03/2022
    14217 08/2022
    13058 02/2022
    13768 05/2022
  63739-997-64 16306 01/2024

Teligent Pharma, Inc. is notifying its distributors via Fed-Ex and is arranging for return of all recalled products.​
FDA Link:
Read more info at FDA.gov
Date:
Oct 5, 2021
Recall:
MiniMed Insulin Pumps
Details:
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product
  • MiniMed™ 600 Series Insulin Pumps
  • Lot codes: Refer to the Medical Device Recalls database entry for each product.
  • Distribution Dates:
    • ◦Model 630G - September 2016 to February 2020
    • Model 670G - May 2015 to December 2020
  • Devices Recalled in the U.S.: 463,464
  • Date Initiated by Firm: November 21, 2019
Device Use

People who have Type 1 diabetes may use the MiniMed™ insulin pump to deliver insulin for the management of their diabetes.
  • The Model 630G insulin pump may be used by persons sixteen years of age and older.
  • The Model 670G insulin pump may be used by persons seven years of age and older.

Reason for Recall

Medtronic is recalling the specified insulin pumps to replace any pump that has a clear retainer ring with one that has the updated black retainer ring at no charge. A replacement insulin pump will be provided even if the clear retainer ring is not damaged and regardless of the warranty status of the pump.

Medtronic previously identified, and informed customers about missing or broken clear retainer ring of the MiniMed™ 630G and 670G insulin pumps. The retainer ring helps to lock the insulin cartridge into place in the pump's reservoir compartment. If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia). Severe hyperglycemia and hypoglycemia can be life-threatening or may result in death.
  • Example of hypoglycemia risk - If the retainer ring is broken or becomes detached from the insulin pump, and the user inserts the reservoir back into the pump while the infusion set is still connected to the body, it could result in a rapid and potentially large infusion of insulin.
  • Example of hyperglycemia risk - The under delivery of insulin could occur if the reservoir is not properly locked in place by the retainer ring, creating a space between the insulin pump and the reservoir, and prevents the pump from pushing the expected insulin into the body, or if the pump stops working due to water entering the insulin pump. This may also contribute to diabetic ketoacidosis.
Serious injuries and deaths have been reported with the use of MiniMed™ 600 series insulin pumps, however those adverse events may not have been directly related to the damaged clear retainer rings that are the basis for this recall. ​
 
FDA Link:
Read more info at FDA.gov
Date:
Oct 5, 2021
Recall:
MiniMed Remote Controllers
Details:
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product
  • All MiniMed Remote Controllers (model MMT-500 and MMT-503) used with a Medtronic MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps
  • Distribution Dates: August 1999 to July 2018
  • Devices Recalled in the U.S.: 31,310
  • Date Initiated by Firm: August 7, 2018

Device Use

People who have diabetes may use the MiniMed insulin pump to deliver insulin for the management of their diabetes. The pump system includes an optional remote controller device which is designed to communicate wirelessly with the pump to deliver a specific amount of insulin to the person with diabetes.

The following table shows the recalled Medtronic remote controllers, used with the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps. The remote controllers impacted by this issue are older models that use previous-generation technology. As of July 2018, Medtronic is no longer manufacturing or distributing these remote controllers.

Reason for Recall

Medtronic is recalling all remote controllers used with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to potential cybersecurity risks. An unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially record and replay the wireless communication between the remote and the MiniMed insulin pump. Using specialized equipment, an unauthorized person could instruct the pump to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis, even death.

If you have never programmed a remote controller ID into the pump and never programmed the easy bolus option, you are not impacted by this vulnerability.

To date, the FDA is not aware of any reports of patient harm related to these potential cybersecurity risks.

Who May Be Affected
  • Any person who uses the remote controller feature with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps
  • Health care providers and caregivers who treat people with diabetes who use remote controllers associated with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps
What to Do

On October 5, 2021, Medtronic began notifying anyone who may still be using the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps and have purchased a remote controller of the expanded recall. Medtronic provided the following instructions:

If you use a recalled remote controller:
  • Stop using the remote controller.
  • Turn off the easy bolus feature.
  • Disconnect the remote controller from your insulin pump:
  • First, you must turn off the radio frequency function and delete all remote controller IDs that are programmed into your insulin pump.
  • Then, follow the instructions in the appendix attached to Medtronic’s letter. The steps to disconnect the remote controller will vary by insulin pump model.
FDA Link:
Read more info at FDA.gov
Date:
Oct 1, 2021
Recall:
Lotrimin and Tinactin Spray Products
Details:
Bayer is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products. Benzene is not an ingredient in any of Bayer Consumer Health products. It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin. Depending on duration and level of exposure, it can result in cancers including leukemia, and blood cancer of the bone marrow and blood disorders which can be life-threatening. Benzene is found in the environment from natural sources and human activity. Humans around the world are exposed to it from multiple sources and pathways, including inhalation, through the skin, and orally. To date, Bayer has no known reports of adverse events related to this recall.

The affected Lotrimin® and Tinactin® spray products are over the counter antifungal products, sold individually or in combo packs. The impacted products are:
  • Lotrimin® Anti-Fungal (AF) Athlete's Foot Powder Spray
  • Lotrimin® Anti-Fungal Jock Itch (AFJI) Athlete's Foot Powder Spray
  • Lotrimin® Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray
  • Lotrimin® AF Athlete's Foot Liquid Spray
  • Lotrimin® AF Athlete’s Foot Daily Prevention Deodorant Powder Spray
  • Tinactin® Jock Itch (JI) Powder Spray
  • Tinactin® Athlete’s Foot Deodorant Powder Spray
  • Tinactin® Athlete’s Foot Powder Spray
  • Tinactin® Athlete’s Foot Liquid Spray
Product images and information on which lot numbers fall under this recall are available at: https://livewell.bayer.com/document/2011External Link Disclaimer.External Link Disclaimer

There are no issues of concern with Lotrimin®/Tinactin® creams, including Lotrimin® Ultra, or any other Bayer products.

The recalled products are all packaged in aerosol spray cans. The products were distributed in the U.S., Puerto Rico, Canada and Mexico through a variety of retail channels.​
 
FDA Link:
Read more info at FDA.gov
Date:
Sep 25, 2021
Recall:
Glucagon Emergency Kit for Low Blood Sugar
Details:
Eli Lilly and Company (NYSE: LLY) is voluntarily recalling lot D239382D, Expiration April 2022, of Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe), to the consumer/user level. Lilly is recalling lot D239382D to the patient level because of a product complaint reporting that the vial of Glucagon was in liquid form instead of the powder form. The firm’s investigation indicates that the liquid in this Glucagon vial could be related to the manufacturing process. The use of the liquid form of this product may fail to treat severe low blood sugar due to loss of potency.

Risk Statement: Severe hypoglycemia in patients with diabetes, if not reversed, can potentially cause adverse health consequences ranging from transient, minor complaints to neurological damage, seizures, and even death if not promptly treated. Associated with the one product complaint, it was reported to Lilly that the involved patient experienced lack of drug effect and also reported subsequent seizures.
FDA Link:
Read more info at FDA.gov
Date:
Sep 16, 2021
Recall:
Chantix
Details:
Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure.

Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.i

Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke.ii

Smoking is also associated with many other cancers, as well as with cardiovascular disease and lung disease.iii CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their healthcare provider about alternative treatment options. To date, Pfizer has not received reports of adverse events assessed to be related to this recall.​
 
FDA Link:
Read more info at FDA.gov
Date:
Sep 13, 2021
Recall:
Ruzurgi (amifampridine) 10 mg
Details:
Plainsboro, New Jersey, Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10 mg tablets to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results.

Oral products heavily contaminated with yeast, mold, and aerobic bacteria may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions such as Lambert Eaton Syndrome (LEMS) increases the concern for serious infections.

The product is used as a treatment for LEMS in patients ages 6 to less than 17 and is packaged in 100 count bottles (NDC: 49938-110-01). The affected Ruzurgi® (amifampridine) tablets lots include the following control numbers and expiration dates:

Control Number 18038, Expiration 03/2023

Control Number 18039, Expiration 03/2023

Control Number 18079, Expiration 05/2023

The Control Number is located to the right of the bottle’s front panel below the D2 Barcode.

Ruzurgi® (amifampridine) was distributed worldwide to specialty pharmacies and physicians.

Jacobus was informed of this issue by their Canadian partner that was conducting confirmatory full testing on Control Number 18038. Jacobus conducted an expanded investigation which identified Control Numbers 18039 and 18079.

Control Number 18038 was distributed between 05/25/2021 – 08/26/2021 (Canada only)
Control Number 18039 was distributed between 06/01/2021 – 08/10/2021
Control Number 18079 was distributed between 08/10/2021 – 08/30/2021

Jacobus Pharmaceutical Company Inc is notifying its distributors and customers via regular mail and electronic mail and is arranging for return of all recalled products. Consumers that have Ruzurgi® (amifampridine) which is being recalled should stop using and return this product.​
FDA Link:
Read more info at FDA.gov
Date:
Sep 8, 2021
Recall:
Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (“Firvanq®”)
Details:
Wilmington, MA, Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (“Firvanq®”) to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq diluent bottle.

Risk Statement: Vancomycin may not be completely solubilized in the FIRST-PPI diluent which could lead to doses above or below those recommended in the label.There is reasonable probability that the administration of inappropriate doses of oral vancomycin may lead to persistent diarrhea associated with dehydration and electrolyte abnormalities, recurrence of Clostridium difficile (C. difficile) infection, its progression to severe colitis, colon perforation requiring colectomy, and potentially death. Especially, the elderly and immunocompromised patients are vulnerable to the complications of C. difficile infection. To date, Azurity has not received any reports of adverse events related to this recall.
FDA Link:
Read more info at FDA.gov
Date:
Aug 27, 2021
Recall:
Lidocaine HCI Topical Solution
Details:
Teligent Pharma, Inc. is voluntarily recalling one lot of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint.

Risk Statement: Use of the super potent product would result in a higher than intended lidocaine dose above that intended.  An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient.  Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly. If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result. Adults and the elderly who are more likely to use this product as well as children of lower body weight are more likely to experience local anesthetic systemic toxicity if a higher than intended lidocaine concentration is administered. To date, Teligent Pharma, Inc. has not received any reports of adverse events related to this recall  

The product is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract and is packaged in a 50ml glass bottle with a screw cap with the identification NDC# 52565-009-50.  The affected Lidocaine HCl Topical Solution 4% lot number and expiration date are:  Lot # 14218, Exp. 09/2022.  The product can be identified by the following labeling:  Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL).   Product was distributed at the wholesale and retail distribution levels in the US and Canada.​
FDA Link:
Read more info at FDA.gov
Date:
Aug 16, 2021
Recall:
Four Additional Lots of CHANTIX (varenicline) Tablets Recalled by Pfizer
Details:
Pfizer is recalling an additional four lots of Chantix 0.5mg/1 mg due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.
FDA Link:
Read more info at FDA.gov
Date:
Aug 6, 2021
Recall:
Atovaquone Oral Suspension
Details:
Atovaquone Oral Suspension, USP 750 mg/5mLto the consumer level. The recall is based on customer complaints of unusual grittiness in the product, which KVK has determined was most probably caused by prolonged exposure of these product lots to extremely cold weather during shipment.

Exposure of Atovaquone Oral Suspension to extremely low temperatures, during shipment (the product is required to be protected from freezing temperatures), may result in changes to the effectiveness, appearance, taste and thickness of the liquid. Severely immunocompromised patients who receive less effective Atovaquone Oral Suspension may experience inadequate treatment of serious and life-threatening infections. To date, KVK Tech is not aware of any adverse events associated with this problem.

Atovaquone is a prescription drug labeled to treat Pneumocystis jiroveci [Pneumocystis carinii] pneumonia, a type of pneumonia most likely to affect people with human immunodeficiency virus (HIV) in teenagers and adults and is also used to prevent immunocompromised patients from contracting this type of pneumonia.
 
FDA Link:
Read more info at FDA.gov
Date:
Jul 16, 2021
Recall:
CHANTIX (Varenicline) Tablets
Details:
Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

The NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets  and photos of the products can be found by clicking the link below.

The product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from June 2019 to June 2021. 
FDA Link:
Read more info at FDA.gov

Disclaimer: Navitus Health Solutions, LLC is a transparent Pharmacy Benefit Manager for a variety of health care plans. Navitus is not owned or operated by an entity related to the pharmaceutical manufacturing industry. Navitus is also not responsible for the manufacture, distribution or recall of any medication. This notification is meant solely to provide information to our clients, members and policyholders, regarding the various recalls of medications by the FDA. Navitus assumes no liability for the information contained in these notifications.