After finding high levels of a probable carcinogen in samples of the common diabetes med metformin, the FDA has scrambled to get affected lots out of consumers’ hands. Now, the agency has spotted a sixth drugmaker with a contaminated version of the drug.
New Jersey-based Bayshore Pharmaceuticals has voluntarily recalled one lot each of its 500- and 750-milligram extended-release metformin after the FDA found high levels of probable carcinogen N-nitrosodimethylamine (NDMA) in tested samples.
The recalled lots were manufactured by Beximco Pharmaceuticals in Dhaka, Bangladesh, in June 2019 for U.S. distribution, the FDA said Thursday.
Bayshore was notified of possible NDMA contamination after FDA testing found abnormally high levels of the carcinogen in a sampled lot of the drugmaker’s generic metformin. Bayshore then conducted its own testing on eight lots of the drug that used the same active pharmaceutical ingredients as the failed lot.
With those tests, Bayshore identified two lots that showed high NDMA levels and launched a voluntary recall. Both Bayshore and Beximco say they have not been notified of any side effects.
Bayshore is the most recent drugmaker to pull its version of metformin off shelves after FDA investigators identified high levels of NDMA, the compound also linked to global recalls of heartburn med Zantac and a range of “sartan”-based high blood pressure drugs.
The FDA began requesting voluntary recalls of certain metformin products in May after internal testing contradicted the agency’s earlier findings of normal NDMA levels in tested samples.
Last month, Lupin Pharmaceuticals pulled all lots of its extended-release metformin after discovering high levels of NDMA in their sample lots.
The recall included the 500- and 1,000-milligram versions sold in 60-, 90- and 100-count bottles distributed between early November and late May, Lupin said. The Indian company previously recalled just one lot of its 500-mg version of metformin back in early June.
Just days before, the FDA had said Virginia-based Granules Pharmaceuticals would pull its own version of extended-release metformin based on the same contamination concerns.
Granules noted that it had found unacceptably high levels of NDMA in just one of 12 tested batches that reached distribution. The recall, however, covered all 12 batches “out of an abundance of caution” and includes the 750-mg formulation in 100- and 500-count bottles.
The FDA in May asked five drugmakers, including Lupin, to withdraw their products from shelves after identifying abnormally high NDMA.
The FDA said it would work with the companies to determine whether the recommended recalls would cause a shortage in the U.S. The move didn’t apply to metformin’s immediate-release formulation, and the FDA specified that “there are additional manufacturers of the metformin ER formulation that supply a significant portion of the U.S. market, and their products are not being recalled.”
The other drugmakers included Apotex, Teva, Amneal and Marksans, all of which launched their own recalls in early June.
Aug 21, 2020