Marksans Recalls More Metformin Due To Probable Carcinogen
Marksans Pharma Limited has expanded its voluntary nationwide recall of 500mg and 750mg metformin hydrochloride extended-release tablets because of contamination with the probable human carcinogen NDMA.
The October 2 recall expansion relates to its earlier June 5 recall, adding an additional 76 unexpired lots of metformin to the recall. Marksans tested their metformin and found NDMA content in some lots was exceeding the acceptable Daily Intake Limit of 96ng/day.
Marksans stated they have not received any adverse event reports related to the recall.
The metformin tablets recalled are used along with diet and exercise to improve blood glucose control in patients with type 2 diabetes mellitus.
The 500mg tablets were packaged in 90 count, 100 count, 500 count and 1000 count packages. The 750mg tablets were packaged in 100 count packages.
The affected 500mg tablets are white to off white, shaped like a capsule and biconvex, with “101” on one side and plain on the other side. The affected 750mg tablets are white to off white, shaped like a capsule and biconvex, with “102” on one side and plain on the other side.
The tablets were sold under the brand name “Time-Cap Labs, Inc.”
The tablets were distributed nationwide to wholesalers who then distributed the tablets to pharmacies. Marksans is notifying distributors and customers via letter and press release and is arranging for return and replacement of recalled tablets.
What To Do If You’re Affected By The Recall
Those with recalled tablets should return them to the place of purchase.
Consumers taking the recalled tablets should continue taking metformin until given a replacement or alternative by a healthcare professional. It can be dangerous for type 2 diabetes patients to stop taking metformin.
Additional Metformin Recalls
This is just the latest in a long string of recalls. A complete list of metformin products recalled in the U.S. can be found here.
The process leading to the recalls began when a December 2019 announcement by Singapore’s Health Sciences Authority said they detected NDMA in three samples of metformin which were at levels above the limit which is internationally acceptable. Testing laboratory Valisure then tested 38 batches of metformin, finding NDMA levels above the FDA’s limit in 16 of the batches. Numerous batches had over 10 times the limit.
Metformin Cancer Lawsuits
Lawsuits now accuse metformin makers of failing to warn the public that their products may cause cancer when they knew or should have known about the cancer risk. Lawsuits also accuse metformin makers of selling a product with a manufacturing defect.