New Jersey-based Bayshore Pharmaceuticals announced a voluntary recall of one lot of Metformin Hydrochloride Extended-Release Tablets.
1,000 count bottles of 500 mg tablets and 100 count bottles of 750 mg tablets were recalled by the company.
The reason for the recall is the detection of N-Nitrosodimethylamine (NDMA) levels above the FDA’s acceptable daily intake limit. NDMA is classified as a probable carcinogen by the EPA and International Agency for Research on Cancer.
The U.S. Food and Drug Administration (FDA) notified Bayshore that lot number 18657 of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg was tested, showing NDMA levels in excess of the daily limit. The FDA recommended recall of the tested lot.
Bayshore responded by not only recalling the lot but, out of an abundance of caution, recalling lot 18641 after testing it and finding levels of NDMA above the daily limit. Bayshore has not received any adverse event reports related to the product.
The recall announcement notes that “it could be dangerous for patients with [type 2 diabetes mellitus] to stop taking their metformin without first talking to their healthcare professionals.”
The affected lots were distributed nationwide to distributors and wholesalers. Bayshore is currently notifying customers affected by the recall by phone and recall notification, arranging for the return of the product. The recall announcement says anyone with an inventory of the product should quarantine the recalled lots immediately.
The FDA said that the recalled lots were manufactured by Beximco Pharmaceuticals in Dhaka, Bangladesh.
Numerous other drugs containing metformin have been recalled due to NDMA contamination, as well as drugs containing ranitidine (Zantac) and valsartan.
Lawsuits say manufacturers of drugs containing ranitidine knew or should have known about the cancer risk associated with their drugs yet failed to warn the public about this risk. 1981 experiment results showed that Zantac could form nitroso derivatives such as NDMA when exposed to human gastric fluid and nitrates, and GlaxoSmithKline responded publicly to these results, showing they were aware of them.
Health insurer Human filed a lawsuit against Teva Pharmaceuticals over valsartan contaminated with NDMA, seeking to recover costs they incurred when they had to recall and replace Teva’s generic valsartan-containing drugs. That lawsuit claimed a manufacturer of ingredients for Teva had “equipment that was rusting” and depositing into “drug product.”
The World Health Organization claims there is “conclusive evidence that NDMA is a potent carcinogen,” claiming there is “clear evidence of carcinogenicity.” Data has shown NDMA to be carcinogenic in many animals, including rats, mice, European, Chinese and Syrian gold hamsters, guinea-pigs, rabbits, ducks, mastomys, frogs, newts and various fish.
For more information on metformin, visit https://www.personalinjurylawcal.com/california-metformin-lawsuits/