A recall of diabetes drugs has expanded to four lots of the widely used type 2 diabetes medication, metformin.
They are being recalled due to possible contamination with a potentially cancer-causing compound.
Indian pharmaceutical company Marksans Pharma Limited is recalling metformin hydrochloride extended-release tablets because their levels of NDMA, a “probable human carcinogen,” were higher than the acceptable daily intake limit of 96 nanograms per day, according to a recall published this week by the US Food and Drug Administration (FDA).
Nostrum Laboratories Inc., based in Kansas City, Missouri, announced Monday that it is voluntarily recalling its metformin HCl extended-release tablets, according to a recall posted by the US Drug & Food Administration.
Testing revealed levels of nitrosamine, or NDMA, above acceptable limits in the recalled tablets.
Metformin tablets are used to treat type 2 diabetes and are designed to lower glucose levels.
This covers 100-tablet bottles of 750 mg Metformin Hydrochloride Extended-Release Tablets, lot Nos. MET200101 and MET200301; and 500 mg Metformin Hydrochloride Extended-Release Tablets, lot Nos. MET100201 and MET100401. All recalled bottles have an expiration date of 05/2022.
Consumers should keep taking their metformin until their doctor or another medical professional comes up with another course of treatment.
“Nostrum Laboratories Inc. is notifying its distributors by
letter and is arranging for return of all recalled products.
Pharmacies that have Metformin HCl Extended-Release Tablets, USP 750 mg, which is being recalled, should return to the place of purchase.
Consumers should consult a health care professional to obtain a replacement or a different treatment option,” the announcement reads.
“It could be dangerous for patients with type 2 diabetes to stop taking their Metformin without first talking to their health care professional.
Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking this drug product.”
The FDA is still investigating where NDMA comes from and how it ends up in metformin products.
Most levels found in medications are generally low and fall within the FDA’s accepted daily intake, but recently recalled medications exceed that.
Marksans Pharma Limited, India, however, did not reveal how much NDMA its recalled products contained.
Consumers with medical questions regarding the recall can email Nostrum at [email protected] or call the company at 816-308-4941 Monday through Friday, 9 a.m. to 6 p.m., Eastern time.
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