At August 19 Bayshore Pharmaceuticals, LLC announced recalling one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, 1000 count bottles and one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 count bottles within expiry to the consumer level due to the detection of N-Nitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit. According to the FDA information it was voluntary recall.
Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. NDMA (N-nitroso-dimethylamine) has been classified as a Group 2A compound, thereby defining it as “probably carcinogenic to humans.” FDA has set daily acceptable intake limits on NDMA in pharmaceuticals of 96 nanograms daily (immediate release(IR) dose is 0.038ppm based on 2550 mg maximum daily dose (MDD); extended release (ER) dose is 0.048 ppm based on 2000 mg MDD).
The medicine was produced by Beximco Pharmaceuticals Limited, Dhaka, Bangladesh in June 2019, for U.S. distribution by Bayshore, and according to the laboratory analyses from 02/04/2020 and 06/03/2020 from FDA were approved that drug consist more NDMA (N-nitroso-dimethylamine) than FDA was okayed.
Sixth Drugmaker With a Contaminated Version Of the Drug
To date Bayshore Pharmaceuticals is 6 drugmakers with a contaminated version of the drug. The other drugmakers included Apotex, Teva, Amneal and Marksans, all of which launched their own recalls in early June.
At their website FDA published short list of recalled metformin products, that includes more than 100 positions.
Bayshore said it had tested samples from 8 lots manufactured using the same active pharmaceutical ingredient of the failed lot. Out of the 8 lots, 1 lot (Lot number 18657) of 750 mg tablets and 1 lot (Lot number 18641) of 500 mg tablets have showed NDMA levels in excess of the Acceptable Daily Intake Limit.
Potential Risks
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
“Patients who have received impacted lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.
According to the FDA, it could be dangerous for patients with this serious condition to stop taking their Metformin without first talking to their healthcare professionals,” FDA informed.
“The affected Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 750 mg, lots were distributed nationwide in the USA by Bayshore directly to Wholesalers and Distributors. Bayshore Pharmaceuticals, LLC is in the process of notifying its customers affected by this recall by phone and through recall notification and is arranging for return of the entire recalled product.
Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the products being recalled should contact Bayshore Pharmaceuticals LLC Information by phone at: 877-372-6093.”
