Second Manufacturer Recalls Metformin Extended Release Tablets

Image: FDA.

Another manufacturer has recalled Metformin extended release tablets, which is prescribed to people suffering from type 2 diabetes.

Amneal Pharmaceuticals of Bridgewater, New Jersey, is recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg.

Amneal was notified by the U.S.Food and Drug Administration that testing of seven lots of Metformin tablets showed N-Nitrosodimethylamine (NDMA) amounts above acceptable levels. The FDA recommended the recall of the seven tested lots. Amneal decided to extend the recall to all lots of Metformin extended release tablets. To date, the manufacturer has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP, are not affected by this recall.

NDMA is classified as a probable human carcinogen, a substance that could cause cancer. It is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables.

The Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.

Metformin HCl Extended Release Tablets, USP, 500 mg

Metformin HCl Extended Release Tablets, USP, 750 mg

The tablets were distributed nationwide in the US directly to wholesalers, distributors, retailers and repackagers.

Amneal is notifying its direct customers and retailers via mail and is arranging for return of all the recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers who purchased the impacted product directly from Amneal may call Amneal at 1-833-582-0812 or email to AmnealProductRecallDS@amneal.com, Monday–Friday, 8 a.m.–5 p.m. for further information.

If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at 1-877-835-5472, Monday – Friday, 8:00 am – 6:00 pm, EST, or via e-mail at DrugSafety@amneal.com.

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.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

The FDA announced last week that testing revealed NDMA in several lots of the extended-release formulation of metformin. The agency has contacted five firms to recommend they recall their products. Apotex Corp was the first to recalling all lots of the extended release tablets. No other recalls have been announced so far. For more information, visit https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.