On November 2, Nostrum Laboratories, Inc. announced about voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750 mg to the consumer level. The company found out, that Metformin HCl Extended Release Tablets, USP 750 mg contain levels of nitrosamine impurities above the ADI limit of 96 ng/day.
At first, drug was recalled at May: “FDA is alerting patients and health care professionals to two voluntary recalls of extended release (ER) metformin by Marksans Pharma and Sun Pharmaceutical Industries. The companies are recalling metformin because it may contain N-nitrosodimethylamine (NDMA) above the acceptable intake limit.
Marksans expanded its voluntary recall to include 76 additional unexpired lots of metformin ER tablets (500 mg and 750mg) labeled as Time-Cap Labs.
Sun voluntarily recalled one lot of Riomet ER, metformin hydrochloride for extended release oral suspension (500 mg per 5 mL).”
NDMA
N-Nitrosodimethylamine (NDMA), a known animal carcinogen and a probable human carcinogen. Back in May 2020, the Food and Drug Administration (FDA) announced it had found high levels NDMA in certain batches of the type-2 diabetes drug Metformin.
NDMA is a semi-volatile organic chemical that can form naturally or unintentionally through industrial processes. Unintentional NDMA can form as a byproduct of the chlorination of wastewater and drinking water, but NDMA can also be formed through natural processes.
The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September 2020.
N-Nitrosodimethylamine is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
If You Get a Recalled Drug From Nostrum Laboratories
“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 place of purchase.
Consumers should consult a healthcare professional to obtain 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 healthcare professional. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product,” – the FDA said.
The Association reminds that all customers should contact their physician or pharmacy for further medical advice. 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.
Need to remember that patients taking recalled ER metformin should continue taking it 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. FDA recommends that health care professionals continue to prescribe metformin when clinically appropriate.
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