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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:
Dec 27, 2022
Recall:
Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial
Details:

Accord Healthcare, Inc. is voluntarily recalling a single lot of Daptomycin for Injection 500 mg/vial, and Daptomycin for Injection 350 mg/vial product contained in cartons imprinted with lot # R2200232 Exp: 01/2025 to the consumer/user level.

This product is being recalled because Accord received a product complaint report from a hospital pharmacy that vials labeled as “Daptomycin for Injection 500 mg/vial” were found in cartons labeled as “Daptomycin for Injection 350 mg/vial”. The lot and expiration date printed on the outer carton and inner vial are the same and correspond to “Daptomycin for Injection 500 mg/vial.” Accordingly, Accord is voluntarily recalling all of lot #R2200232, Daptomycin for Injection 500 mg/vial, which may be in outer cartons that read “Daptomycin for Injection 500 mg/vial” OR “Daptomycin for Injection 350 mg/vial.” 
 

Product NDC Lot number/Expiration Date
Daptomycin for Injection 500 mg/vial 16729-435-05 R2200232, 01/2025
Daptomycin for Injection 350 mg/vial 16729-434-05


Risk Statement: Administration of Daptomycin 500 mg/vial, to the population most at risk which are children or patients with renal impairment, there is a reasonable probability that the likelihood of the labeled warnings can potentially be increased if a higher than the intended dose is used which could lead to serious adverse health consequences. If these reactions occur, they may require medical treatment such as hemodialysis and systemic glucocorticoids. To date, Accord has not received any reports of adverse events related to this recall.

The product is used for the treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureaus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).

The lot number, NDC number and expiration date of affected Daptomycin 500 mg/vial and Daptomycin 350 mg/vial product is shown in the table below:
 

Product NDC Lot number/Expiration Date
Daptomycin for Injection 500 mg/vial 16729-435-05 R2200232, 01/2025
Daptomycin for Injection 350 mg/vial 16729-434-05


The product can be identified by the outer carton and inner vial as given in the image below:

Daptomycin for Injection 350 mg/vial and 500 mg/vial were distributed nationwide to wholesale.

Accord is notifying or has notified its Wholesalers and Distributors by letter and is arranging for return of all recalled products. Wholesalers and Distributors that have product which is being recalled should discontinue distribution of the product.

For any questions regarding this recall, contact Accord Healthcare, Inc. by phone at 1-855-869-1081, fax: 1-817-868-5362 or e-mail at rxrecalls@inmar.com Monday to Friday during business hours 8 am to 5 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.

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:
Dec 21, 2022
Recall:
Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Four Lots of Quinapril Tablets
Details:
Lupin Pharmaceuticals Inc. is voluntarily recalling four (4) lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has received no reports of illness that appear to relate to this issue.

Lupin discontinued the marketing of Quinapril tablets in September 2022.

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.
FDA Link:
Read more info at FDA.gov
Date:
Dec 16, 2022
Recall:
Detect Covid-19 Test Lots
Details:

Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test™, our molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes Covid-19) in self-collected nasal swabs. The recall affects a total of 11,102 tests shipped to customers from July 26th, 2022 through August 26th, 2022. The test was granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on October 28, 2021.

There is an increased chance that the tests from the lot numbers listed below may give false negative results. Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots. To date, Detect has not received any reports of false negative results related to the affected lots and is issuing this recall out of an abundance of caution. The reliability of positive test results is not affected.

Below is a list of the affected lots. The lot number can be found on the side of each test box along with the Use By date.
 

Lot Number Use By Date Number of Tests Shipped
HB264 1/1/2023 7,382
HY263 1/1/2023 1,800
HY264 1/1/2023 1,920
 

Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test™, our molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes Covid-19) in self-collected nasal swabs. The recall affects a total of 11,102 tests shipped to customers from July 26th, 2022 through August 26th, 2022. The test was granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on October 28, 2021.

There is an increased chance that the tests from the lot numbers listed below may give false negative results. Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots. To date, Detect has not received any reports of false negative results related to the affected lots and is issuing this recall out of an abundance of caution. The reliability of positive test results is not affected.

Below is a list of the affected lots. The lot number can be found on the side of each test box along with the Use By date.

Detect is notifying all customers and distributors affected by the recall. Anyone in possession of any unused tests from the affected lots should dispose of the tests. The outer packaging is recyclable while all the test components can be discarded as regular trash. Detect Hubs are not affected by the recall and do not need to be discarded.

Test users who attempt to use recalled tests will be notified in the Detect App™ that the test has been recalled and may not be used.

Detect, Inc. will issue a refund* for the affected tests (as verified by Detect) upon customers’ acknowledgement of receipt of the recall-related communication and confirmation that any affected tests in possession have been disposed of.

*Detect Hubs, unrecalled tests, and shipping charges are not eligible for a refund.

We apologize for any inconvenience and thank our Detect customers.

Please contact our customer support team for questions and further assistance.
Phone: (855) 322 3692
Email: support@detect.com
FDA Link:
Read more info at FDA.gov
Date:
Nov 29, 2022
Recall:
Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton
Details:
FOR IMMEDIATE RELEASE – November 28, 2022 – Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. A total of 63 lots are now being recalled to the consumer level. All the recalled lots are listed in the table below, with the additional fourteen (14) lots shown in BOLD and RED. The additional lots were distributed October 26, 2021 through April 25, 2022.
 
Brand Lot Expire Date
Exela P0001178 05/2023
Exela P0001298 08/2023
Exela P0001301 08/2023
Exela P0001313 08/2023
Exela P0001314 08/2023
Exela P0001317 08/2023
Exela P0001330 09/2023
Exela P0001370 10/2023
Exela P0001371 10/2023
Exela P0001372 10/2023
Exela P0001433 11/2023
Exela P0001434 11/2023
Exela P0001442 11/2023
Exela P0001443 12/2023
Exela P0001464 09/2023
Exela P0001467 12/2023
Exela P0001468 12/2023
Exela P0001469 12/2023
Exela P0001470 12/2023
Exela P0001472 12/2023
Exela P0001486 12/2023
Exela P0001495 12/2023
Exela P0001505 12/2023
Exela P0001506 12/2023
Exela P0001509 12/2023
Exela P0001510 12/2023
Exela P0001511 12/2023
Exela P0001512 12/2023
Exela P0001532 12/2023
Exela P0001560 01/2024
Exela P0001561 01/2024
Exela P0001562 01/2024
Exela P0001564 01/2024
Exela P0001566 01/2024
Exela P0001567 01/2024
Exela P0001568 01/2024
Exela P0001571 02/2024
Exela P0001572 02/2024
Exela P0001573 02/2024
Exela P0001574 02/2024
Exela P0001578 02/2024
Exela P0001579 02/2024
Exela P0001580 02/2024
Exela P0001583 02/2024
Exela P0001586 02/2024
Exela P0001587 02/2024
Exela P0001588 02/2024
Exela P0001593 02/2024
Exela P0001594 02/2024
Exela P0001610 02/2024
Exela P0001618 02/2024
Exela P0001619 02/2024
Exela P0001644 03/2024
Exela P0001645 03/2024
Exela P0001646 03/2024
Exela P0001654 02/2024
Civica P0001490 12/2023
Civica P0001497 12/2023
Civica P0001600 02/2024
Civica P0001663 03/2024


The Exela product (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) can be identified by the NDC numbers, and by the yellow flip-top safety cap on the 50 mL vial. The carton bears a purple stripe containing concentration information and the manufacturer name “Exela Pharma Sciences” in the lower right-hand corner. The vial label bears a purple stripe containing concentration information with the name “Exela Pharma Sciences” on the back.

The Civica Product (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1) can be identified by the NDC numbers, by the yellow flip-top safety cap on the 50 mL vial, and by the carton which bears a green stripe containing concentration information and the manufacturer name “Civica” in the lower right-hand corner. The vial label bears a green stripe containing concentration information with the name “Civica” on the back.

All the above-listed lots are supplied in 20 count cartons only. This recall is not expected to cause drug shortage.

Product was distributed nationwide to wholesalers, distributors, and other customers between October 26, 2021 and August 10, 2022.

Exela is notifying its customers by e-mail and certified mail and is arranging for return and replacement of all recalled product directly to Exela. Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela.

Customers with questions regarding this recall can contact Exela by phone (828-341-6118) or email ( recall@exela.us ) Monday through Friday, 9:00am – 5:00pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.

Additionally, adverse events or quality problems experienced with the use or handling of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

FDA Link:
Read more info at FDA.gov
Date:
Oct 25, 2022
Recall:
Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg
Details:

Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two (2) lots (refer table below) of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the consumer level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit.

Aurobindo Pharma USA, Inc. began shipping of the subject batches, QE2021005-A and QE2021010-A to customers nationwide May 2021.
 

NDC No. Product Name, strength, and pack Lot number Expiry
65862-162-90 Quinapril and Hydrochlorothiazide
Tablets USP, 20mg / 12.5mg,
90’s HDPE bottle
QE2021005-A 01/2023
QE2021010-A


Risk Statement: 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. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

Quinapril and Hydrochlorothiazide Tablets, USP are fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide. This product is indicated for the treatment of hypertension, to lower blood pressure. Patients should contact their doctor or health care provider about whether to continue taking their medication, or whether to consider an alternative treatment prior to returning their medication.

Quinapril and Hydrochlorothiazide Tablets USP 20 mg / 12.5 mg are “Pink colored, scored, round shaped, biconvex, film-coated tablets, debossed with ‘D’ on scored side and ‘19’on other side”, supplied in 90’s HDPE bottle.

The product label is as shown below:

Qualanex, on behalf of Aurobindo Pharma USA, Inc., will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

FDA Link:
Read more info at FDA.gov
Date:
Oct 17, 2022
Recall:
Omnipod DASH Insulin Management System's Personal Diabetes Manager
Details:
Insulet is recalling the Omnipod DASH Insulin Management System’s Personal Diabetes Manager (PDM) after receiving reports of PDM battery issues, including:
  • Battery swelling
  • Fluid leakage from the battery
  • Extreme overheating that may pose a fire hazard
Users could be exposed to battery fluid and extreme heat, including the potential for an explosion and/or fire, which could lead to serious injury or death.
FDA Link:
Read more info at FDA.gov
Date:
Oct 14, 2022
Recall:
Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton
Details:

Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20- count carton, to the consumer level.

Risk Statement: The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts. There have been no reports of sterility failures.

The product is used for treatment of metabolic acidosis and is packaged in a 50 mL glass vial, 20 vials per carton. The vials are labeled with Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Figure 1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1, Figure 2).

The affected Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:
 

Brand Lot Expire Date
Exela P0001370 10/2023
Exela P0001371 10/2023
Exela P0001372 10/2023
Exela P0001433 11/2023
Exela P0001434 11/2023
Exela P0001443 12/2023
Exela P0001468 12/2023
Exela P0001469 12/2023
Exela P0001470 12/2023
Exela P0001495 12/2023
Exela P0001505 12/2023
Exela P0001506 12/2023
Exela P0001509 12/2023
Exela P0001510 12/2023
Exela P0001511 12/2023
Exela P0001512 12/2023
Exela P0001560 01/2024
Exela P0001561 01/2024
Exela P0001562 01/2024
Exela P0001564 01/2024
Exela P0001566 01/2024
Exela P0001567 01/2024
Exela P0001568 01/2024
Exela P0001571 02/2024
Exela P0001572 02/2024
Exela P0001573 02/2024
Exela P0001574 02/2024
Exela P0001578 02/2024
Exela P0001579 02/2024
Exela P0001580 02/2024
Exela P0001583 02/2024
Exela P0001586 02/2024
Exela P0001587 02/2024
Exela P0001588 02/2024
Exela P0001593 02/2024
Exela P0001594 02/2024
Exela P0001610 02/2024
Exela P0001618 02/2024
Exela P0001619 02/2024
Exela P0001644 03/2024
Exela P0001645 03/2024
Exela P0001646 03/2024
Exela P0001654 02/2024
Exela P0001662 03/2024
Exela P0001664 03/2024
Exela P0001730 05/2024
Civica P0001497 12/2023
Civica P0001600 02/2024
Civica P0001663 03/2024


The Exela product (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) can be identified by the NDC numbers, and by the yellow flip-top safety cap on the 50 mL vial. The carton bears a purple stripe containing concentration information and the manufacturer name “Exela Pharma Sciences” in the lower right-hand corner. The vial label bears a purple stripe containing concentration information with the name “Exela Pharma Sciences” on the back.

The Civica Product (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1) can be identified by the NDC numbers, by the yellow flip-top safety cap on the 50 mL vial, and by the carton which bears a green stripe containing concentration information and the manufacturer name “Civica” in the lower right-hand corner. The vial label bears a green stripe containing concentration information with the name “Civica” on the back.

All the above-listed lots are supplied in 20 count cartons only. This recall is not expected to cause drug shortage.

Product was distributed nationwide to wholesalers, distributors, and other customers between December 16, 2021 and August 10, 2022.

Exela is notifying its customers by e-mail and certified mail and is arranging for return and replacement of all recalled product directly to Exela. Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela.

Customers with questions regarding this recall can contact Exela by phone (828-341-6118 x1017) or email ( recall@exela.us ) Monday through Friday, 9:00am – 5:00pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.
FDA Link:
Read more info at FDA.gov
Date:
Sep 29, 2022
Recall:
Clopidogrel 75mg Tablets and Atenolol 25mg Tablets
Details:
Golden State Medical Supply, Incorporated (GSMS, Inc.) - Camarillo, CA has initiated a voluntary recall of the products listed in the table below because a report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot# GS046745 was mislabeled as Atenolol 25mg Tablets. This voluntary recall only affects products with lot# GS046745. No other Clopidogrel or Atenolol products marketed by GSMS, Inc. are impacted. Both products are being recalled out of abundance of caution.

 
Product Description GSMS NDC Lot # Expiration Date
Clopidogrel 75mg Tablets, 1,000 Count Bottle 51407-032-10 GS046745 12/2023
Atenolol 25mg Tablets, 1,000 Count Bottle 60429-027-10 GS046745 12/2023

Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Clopidogrel is prescribed to lower the risk of having a stroke, blood clot, or serious heart problem for patients who have had heart attack, severe chest pain, or circulation problems as indicated in the product labeling.
FDA Link:
Read more info at FDA.gov
Date:
Jul 15, 2022
Recall:
Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination
Details:
Vi-Jon, LLC is expanding its voluntary recall to include all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry to the consumer level.  The recall was initiated after 3rd Party and Vi-Jon, LLC microbial testing identified the presence of 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 received one report of an adverse reaction potentially related to this recall.  Vi-Jon, LLC is in the process of investigating this report.

The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in ½ to 6 hours. The product is packaged in a 10 oz clear round plastic bottle.

The list of affected brands can be found on the FDA website.
FDA Link:
Read more info at FDA.gov
Date:
Jul 5, 2022
Recall:
Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100)
Details:

FOR IMMEDIATE RELEASE - PITTSBURGH – July 5, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens to the consumer level. This product is not the branded Semglee® pen but the unbranded Insulin Glargine-yfgn pens. This batch is being recalled due to the potential for the label to be missing on some pens.

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 pens 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 pertains only to the unbranded interchangeable biosimilar Insulin Glargine-yfgn pens and does not impact the branded interchangeable biosimilar Semglee® (insulin glargine-yfgn) injection pens.

This 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 product is packaged in a 3 mL prefilled pen which is then packaged in cartons of five pens. 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 April 4, 2022 and May 5, 2022. The recalled batch information is as follows:
 

NDC # Name and Strength Size Batch # Expiry
49502-394-75 Insulin Glargine (Insulin glargine-yfgn)
Injection, 100 units/mL (U-100)
3 mL Prefilled Pen BF21002895 Aug 2023


The company has initiated the recall of batch BF21002895 by notifying its distributors and retailers by letter and arranging for return of all recalled products. Following are actions for wholesalers, retailers and consumers:

  • Wholesalers: 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 via Microsoft Excel file to mylan8775@sedgwick.com within five (5) business days. Sedgwick will notify your retail level customers that received the affected batch.
  • Retailers: Immediately examine your inventory, quarantine and discontinue distribution of this batch. In addition, if you have further distributed the subject batch, please identify the consumer and notify them of this product recall and to immediately return any unlabeled product per the instructions below.
  • Consumers: If you have an unlabeled pen, please contact Sedgwick at 1-877-643-8438 for the documentation packet to return the product.

Consumers with questions regarding this recall can contact Viatris Customer Relations by phone at 1-800-796-9526 or by email at 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:
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

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.