Safety Report: Amneal Pharmaceuticals LLC Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg - recalled due to Due to detection of N-Nitrosodimethylamine (NDMA), USA

United States

Company name: Amneal Pharmaceuticals LLC
Brand name: Amneal
Product recalled: Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg
Reason of the recall: Due to detection of N-Nitrosodimethylamine (NDMA)
FDA Recall date: June 01, 2020
Recall details: Amneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level. Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels.

FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution. Further scientific evaluations are ongoing at Amneal. To date, Amneal 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.

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 found in water and foods, including meats, dairy products, and vegetables. Metformin HCl Extended-Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. 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
53746-178-01. 100 count bottles
53746-178-05. 500 count bottles
53746-178-10. 1000 count bottles
53746-178-90. 90 count bottles
53746-178-Bulk. Bulk Box
65162-178-09. 90 count bottles
65162-178-10. 100 count bottles
65162-178-11. 1000 count bottles
65162-178-50. 500 count bottles

Metformin HCl Extended-Release Tablets, USP, 750 mg
53746-179-01. 1000 count bottles
53746-179-Bulk. Bulk Box
65162-179-10. 100 count bottles

The affected Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, lots were distributed nationwide in the US directly to Wholesalers, Distributors, Retailers, and Repackagers.

Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for the return of all the recalled products. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended

Source: FDA