Drug Recalls

On March 31, 2021 -

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.



For more information about this recall, please visit the FDA website



On March 24, 2021 -

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.
 



For more information about this recall, please visit the FDA website



On March 24, 2021 -

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.
 



For more information about this recall, please visit the FDA website



On March 9, 2021 -

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.

 

 

A patient who consumes spironolactone 25 mg instead of the prescribed spironolactone 50 mg may experience an elevation in blood pressure or increased swelling caused by excess fluid (edema) if taking the product chronically. 

 

 

 

 

 



For more information about this recall, please visit the FDA website



On February 2, 2021 -

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.

Health Hazard Assessment: Incorrect syringe barrel marking could lead to miscalculation and inaccurate dose administration to patients. In one recalled batch (batch CS008, strength 100 mg/mL), if a consumer used a 150 mg/mL concentration packaged in a barrel corresponding to a l00 mg/mL concentration, patients could receive 3.75 mg of Enoxaparin, instead of 3 mg of Enoxaparin. In another recalled batch (batch CT003, strength 120 mg/0.8mL), if a consumer used a 100 mg/mL concentration packaged in a barrel corresponding to a 150 mg/mL concentration, patients would receive 2 mg of Enoxaparin rather than 2.5 mg of Enoxaparin. Accidental overdosage following administration of enoxaparin sodium injection may lead to bleeding complications. Alternative, if the dose administered is less than prescribed, the patient may be subject to developing some blood clotting conditions.

Enoxaparin Sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), Treatment of Acute Deep Vein Thrombosis, prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin and Treatment of Acute ST-Segment Elevation Myocardial Infarction.
 



For more information about this recall, please visit the FDA website



On January, 25, 2021 -

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.
 



For more information about this recall, please visit the FDA website



On January 8, 2021 -

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.

 

 

 

 



For more information about this recall, please visit the FDA website



On January 4, 2021 -

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​.
 



For more information about this recall, please visit the FDA website



On December 29, 2020 -

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.
 



For more information about this recall, please visit the FDA website



On December 9, 2020 -

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.

 



For more information about this recall, please visit the FDA website



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Drug Recall Process

The U.S. Food and Drug Administration (FDA) has jurisdiction over food, drugs, cosmetics, medical devices and other products and services as a monitor over product recalls. In most cases recalls are done voluntarily by the manufacturer or the distributor of the product. In some cases, a company will discover that one of its products is defective and will recall it. In other cases, the FDA will notify a company that one of its products is defective and will suggest or request a recall.

The FDA has guidelines for companies to follow in recalling defective products. These guidelines explain that the FDA expects these firms to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. The guidelines categorize all recalls into one of the three classes according to the level of hazard involved.

  • Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death.
  • Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature.
  • Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violates FDA regulations.


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.

 

This plan, Navitus MedicareRx (PDP), is offered by Navitus Health Solutions and underwritten by Dean Health Insurance, Inc., A Federally-Qualified Medicare Contracting Prescription Drug Plan.