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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:
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
Date:
Jun 16, 2021
Recall:
Hypodermic Needle-Pro Fixed Needle Insulin Syringes
Details:
Smiths Medical has become aware of specific models and lots of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. Markings skewed approximately 20 degrees upward have been identified.

Affected Models and Lot Numbers:
 
Model Number Name Lot Number
4428-1 Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe 28Gx1/2" 1CC 4046543 and 4062235
4429-1 Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe 29Gx1/2" 1CC 4014096, 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238 and 4062242

Please reference the attachment for an illustration of the skewed graduation marking on the syringe barrel.

As a result of this issue, there is potential for administration of an incorrect dose of insulin, which could result in hyperglycemia (which may lead to ketoacidosis) or hypoglycemia (which may lead to seizures). This may result in serious harm or death.
 
FDA Link:
Read more info at FDA.gov
Date:
Jun 11, 2021
Recall:
Metformin HCI Extended-Release Tablets
Details:
Viona Pharmaceuticals Inc., is voluntarily recalling 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. The 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg have been found to contain levels of Nitrosodimethylamine (NDMA) impurities above acceptable daily limits. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India in November 2019, 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.
 
FDA Link:
Read more info at FDA.gov
Date:
May 4, 2021
Recall:
Bupivacaine Hydrochloride Injection and Lidocaine HCI Injection
Details:
Hospira, Inc., a Pfizer company, is voluntarily recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCl Injection, USP 30 mL, to the hospital/institution level due to mislabeling whereby a portion of each lot was incorrectly labeled as the other product. This issue was identified as part of the investigation of a confirmed customer report.

Hospira’s assessment of the potential risk to patients concluded that the use of the impacted product is likely to cause adverse events of moderate to high severity. If 1% lidocaine is administered to the patient instead of 0.5% bupivacaine, the patient may be underdosed, leading to lack of efficacy with potential outcomes such as inadequate pain management, and failure of surgical anesthesia. If 0.5% bupivacaine is administered to the patient instead of 1% lidocaine, an overdose of bupivacaine may occur, which could lead to potential outcomes such as seizures; respiratory abnormalities including low oxygen and/or elevated carbon dioxide in the blood, too much acid in the body fluids, and temporary cessation of breathing; heart abnormalities such as heart contraction and/or relaxation issues, irregular heartbeat, slower than normal heart rate, abnormal heart rhythm in which the ventricles of the heart quiver instead of pumping normally, cardiac arrest and cardiac flatline. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

0.5% Bupivacaine Hydrochloride Injection, USP is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures.

1% Lidocaine HCl Injection, USP is indicated for the production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks when the accepted procedures for these techniques as described in standard textbooks are observed.
 
FDA Link:
Read more info at FDA.gov
Date:
Apr 29, 2021
Recall:
Thyroid Tablets, USP
Details:
Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the Tables 1 and 2 below of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine testing has found these lots to be sub potent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. To date, Acella has received 43 reports of serious adverse events that could possibly be related to this recall.
 
FDA Link:
Read more info at FDA.gov
Date:
Mar 31, 2021
Recall:
Guanfacine Extended-Release Tablets
Details:
Apotex Corp is voluntarily recalling three (3) lots of Guanfacine Extended-Release Tablets 2mg to the consumer level due to trace amounts of Quetiapine Fumarate in one lot RX1663. Out of an abundance of caution, lots RX1662 and RX1664 are also included in the scope of this voluntary recall, as they were manufactured in the same campaign as lot RX1663.

Risk Statement: Administration of Guanfacine Extended-Release Tablets containing trace amounts of Quetiapine Fumarate to a patient can result in the possibility of hypersensitivity reaction and may potentially have additive effects in lowering blood pressure, sleepiness/sedation, and dizziness. Pediatric patients, pregnant patients and older adults may be more likely to experience low blood pressure and dizziness if exposed to the defective product. To date, Apotex Corp has not received any reports of adverse events related to this recall.

Guanfacine is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and can be used with other stimulant medications. Quetiapine is indicated for the treatment of Schizophrenia and other serious mental disorders such as Bipolar disorder manic episodes, Bipolar disorder, and depressive episodes.

The affected Guanfacine Extended-Release Tablets can be identified by NDC numbers stated on label of the product. The lot number and Expiration date are located to the left side of the product description on the label besides the 2D barcode. The affected lots were distributed in the USA between December 22, 2020 to March 19, 2021.
FDA Link:
Read more info at FDA.gov
Date:
Mar 24, 2021
Recall:
Telmisartan Tablets
Details:
Bridgewater, NJ, Alembic Pharmaceuticals, Inc is voluntarily recalling one lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one bottle labelled as 30-count Telmisartan Tablets, USP, 20 mg incorrectly contained 30 tablets of Telmisartan Tablets, USP, 40mg.

Risk Statement: Patients who could be on a doubled dose of telmisartan for a prolonged period of time, could experience low blood pressure, worsening of kidney function, or an elevation of potassium which can be life-threatening. To date, Alembic Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

The product is used for the treatment of hypertension i.e. to lower blood pressure and is packaged in a bottle of 30 tablets having NDC Number 62332-087-30. The affected lot of Telmisartan Tablets, USP, 20 mg is the lot number 1905005661 and the lot expires in March 2022. The wrong product can be identified by checking the shape and embossing details on the tablets i.e. Telmisartan Tablets, USP, 20 mg bottles may incorrectly contain oval shaped White to off-white tablets debossed with L203 on one side instead of correct product i.e. round shaped White to off-white tablets debossed with L 202 on one side. Telmisartan Tablets, USP, 20mg, Lot No. 1905005661 was distributed Nationwide in the USA to wholesalers, retailers, and pharmacies.
FDA Link:
Read more info at FDA.gov
Date:
Mar 24, 2021
Recall:
Acyclovir Sodium Injection
Details:
Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials.

Administration of crystalized Acyclovir Sodium Injection, 50 mg/mL has a potential of life-threatening adverse consequences including injection site inflammation of a vein and local reactions, damage and/or obstruction of blood vessels, which could induce clots, particularly in the lungs, the passage of the particulate matter into the bloodstream may lead to clots resulting in stroke, heart attack, decreased liver or kidney function or death of tissues or cells. To date, Zydus Pharmaceuticals (USA) Inc. has not received any reports of adverse events related to this product recall.

Acyclovir Sodium Injection, 50 mg/mL is indicated for the treatment of herpes simplex infections in immunocompromised patients, severe initial clinical episodes of herpes genitalis in immuno-competent patients, herpes simplex encephalitis, neonatal herpes simplex virus infection and varicella-zoster (shingles) infections in immunocompromised patients. The product is packaged in single-dose glass vials and was distributed nationwide in the USA to Cardinal Health, Amerisourcebergen Drug Corporation and Morris & Dickson Company LLC.

Zydus Pharmaceuticals (USA) Inc. has notified its distributors and customers by email and FedEx overnight courier service and is arranging for the return of all recalled Acyclovir Sodium Injection, 50 mg/mL lots. Hospitals that have the product which is being recalled should stop using it immediately and call our recall coordinating center at 1-855-671-5023 Monday – Friday (excluding holidays), 9:00 am to 5:00 pm EST.
FDA Link:
Read more info at FDA.gov
Date:
Mar 9, 2021
Recall:
Spironolactone tablets
Details:
Bryant Ranch Prepack is voluntarily recalling 4 lots of Spironolactone tablets to the consumer level. The products have been found to be mislabeled, displaying the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles of spironolactone 25 mg may contain Spironolactone 50 mg tablets.
FDA Link:
Read more info at FDA.gov
Date:
Feb 2, 2021
Recall:
Enoxaparin Sodium Injection USP
Details:
Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa. The packaging error was discovered during a customer complaint investigation. To date, Apotex has not received any reports of adverse events related to use of these two batches. The affected product is manufactured by Gland Pharma Limited, Hyderabad, India.
FDA Link:
Read more info at FDA.gov
Date:
Jan 25, 2021
Recall:
Metformin HCI Extended Release Tablets
Details:
Nostrum Laboratories is recalling one lot of Metformin HCl Extended Release Tablets - USP, 750 mg because it has been found they contain levels of nitrosamine impurities above the ADI limit of 96 ng/day, as published in the FDA Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2, 2020.

NDMA is classified as a probable human carcinogen based on results from laboratory tests.

To date, Nostrum Laboratories has not received any reports of adverse events related to this recall.
FDA Link:
Read more info at FDA.gov
Date:
Jan 8, 2021
Recall:
Ketorolac Tromethamine Injection, USP
Details:
Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.
FDA Link:
Read more info at FDA.gov
Date:
Jan 4, 2021
Recall:
Metformin HCI Extended Release Tablets
Details:
Nostrum Laboratories, Inc. is recalling one lot of Metformin HCl Extended Release Tablets - USP, 750 mg (generic equivalent to Glucophage Tablets) because the tablets have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020. This is an expansion of the recall initially announced on November 2, 2020.

NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

To date, Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.​
FDA Link:
Read more info at FDA.gov
Date:
Dec 28, 2020
Recall:
Paroex Chlorhexidine Gluconate Oral Rinse
Details:
Sunstar Americas is recalling Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on October 27, 2020.

Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.

To date, 29 adverse events have been reported to Sunstar Americas related to this recall.

Affected patients tested positive for Burkholderia lata infections, typically found in sputum cultures while under treatment for other serious medical conditions. Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with COVID-19, is particularly unsafe.
FDA Link:
Read more info at FDA.gov
Date:
Dec 9, 2020
Recall:
Anagrelide Capsules, USP
Details:
Torrent Pharmaceuticals Limited is voluntarily recalling one lot of Anagrelide Capsules, USP to the consumer level due to dissolution test failure detected during routine quality testing.

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 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, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.
FDA Link:
Read more info at FDA.gov
Date:
Dec 9, 2020
Recall:
Sildenafil 100mg Tablets and Trazodone 100 mg Tablets
Details:
AvKARE, Pulaski, TN is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a 3rd party facility. 
 
Product Lot Expiration Date Bottle count NDC Number
Sildenafil Tablets, USP 36884 03/2022 100 42291-748-01
Trazodone Tablets, USP 36783 06/2022 1000 42291-834-10

Unintentional consumption of sildenafil may pose serious health risks to consumers with underlying medical issues. 
FDA Link:
Read more info at FDA.gov
Date:
Nov 9, 2020
Recall:
Chlorhexidine Gluconate Oral Rinse USP
Details:
Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 (see specific lots below) to the consumer level. This product is sourced and repackaged from Sunstar Americas Inc. who has notified us the product may be contaminated with the bacteria Burkholderia lata.

Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to Lohxa, LLC related to this recall.
 
FDA Link:
Read more info at FDA.gov
Date:
Nov 3, 2020
Recall:
Metformin HCl Extended Release Tablets, USP 500 mg
Details:
Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 500 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 500 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020.

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. Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.
 
FDA Link:
Read more info at FDA.gov
Date:
Oct 27, 2020
Recall:
Paroex Chlorhexidine Gluconate Oral Rinse USP
Details:
Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia lata.

Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to SAI related to this recall.

The prescription oral rinse product, available through healthcare professionals only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:
  • 1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 ml) chlorhexidine rinse. The bottle has a childproof cap and a 15 ml metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.
 
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.