Diabetes drug recall is expanded to include 76 unexpired lots over contaminant concern

Howard Cohen
·2 min read

One of the manufacturers of a Type 2 diabetes drug, Metformin Hydrochloride Extended-Release Tablets, extended its recall of its 500mg and 750 mg pills, the U.S. Food and Drug Administration reported this week.

Marksans Pharma Limited of India expanded its earlier initiated recall from June 5 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets in both 500 mg and 750 mg packages.

The company performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and found that NDMA content in some lots exceeded the acceptable daily intake limit. There have been no reported adverse effects from anyone taking the medication but the company pulled the drugs “out of an abundance of caution,” its statement said.

NDMA could cause cancer based on lab tests and is an environmental contaminant found in water and foods, including meats, dairy products and vegetables.

Metformin Hydrochloride Extended-Release Tablets are supposed to be used in conjunction with diet and exercise to improve blood glucose control in adults with type 2 diabetes.

What to look for

The tablets are packaged in bottles with the following NDC numbers in different packing configurations.

Marksans Pharma’s Metformin Hydrochloride Extended-Release Tablets, 500 mg, were part of an extended recall on Oct. 2, 2020.
Marksans Pharma’s Metformin Hydrochloride Extended-Release Tablets, 500 mg, were part of an extended recall on Oct. 2, 2020.

▪ Metformin Hydrochloride Extended-Release Tablets, USP 500mg:

90 counts: 49483-623-09

100 counts: 49483-623-01

500 counts: 49483-623-50

1000 counts: 49483-623-10

Marksans Pharma’s Metformin Hydrochloride Extended-Release Tablets, 750 mg, were part of an extended recall on Oct. 2, 2020.
Marksans Pharma’s Metformin Hydrochloride Extended-Release Tablets, 750 mg, were part of an extended recall on Oct. 2, 2020.

▪ Metformin Hydrochloride Extended-Release Tablets, USP 750mg:

100 counts: 49483-624-01

What the tablets look like

The affected Metformin Hydrochloride Extended-Release Tablets, USP 500mg, are white to off white, capsule shaped, biconvex tablets. The pills have ‘101’ on one side and are plain on the other side.

Metformin Hydrochloride Extended-Release Tablets, USP 750mg, are white to off white, capsule shaped, biconvex tablets. These are marked ‘102’ on one side and are plain on the other side.

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg were distributed by Time-Cap Labs, Inc. from New York nationwide across the U.S. to wholesalers who further distributed the medication to pharmacies.

What to do

Consumers with questions regarding this recall and return can contact Irene McGregor, vice president of regulatory affairs of Time-Cap Labs, by phone at 631-753-9090, ext. 160, from 8 a.m. to 5 p.m. eastern Monday to Friday. Or e-mail her at imcgregor@timecaplabs.com.

According to the company, consumers taking these recalled product lots of Metformin Tablets should continue taking them until a doctor or pharmacist gives them a replacement or a different treatment option.

“It could be dangerous for patients with type 2 diabetes to stop taking their Metformin without first talking to their health care professional,” Time-Cap Labs said.

If in doubt, contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this drug.