As expected, more diabetes medicine recalled because too much of a carcinogen was found
For the second time in a week, a maker of Type 2 diabetes drug Metformin announced a recall because the drug might have too much NDMA, a substance that can cause cancer in certain amounts.
The FDA said it found too much NDMA (N-Nitrosodimethylamine) in seven lots of Amneal’s Pharmaceuticals Metformin Hydrochloride Extended Release 500 mg, 750 mg tablets. According to the Amneal-written, FDA-posted recall notice, the FDA recommended recalling those seven lots and Amneal decided to yank all unexpired lots on the market.
Apotex recalled its extended release Metformin last week for the same reason, the first of what the FDA claims are five companies the agency asked to make voluntarily recalls of Metformin.
On the bottle labels, you’ll find the NDC Nos. for the recalled 500 mg tablets: 53746-178-01; 53746-178-05; 53746-178-10; 53746-178-90; 53746-178-Bulk; 65162-178-09; 65162-178-10; 65162-178-11; and, 65162-178-50.
The NDC Nos. for the recalled 750 mg tablets: 53746-179-01; 53746-179-Bulk; and 65162-179-10.
Consumers who bought the Metformin directly from Amneal can email AmnealproductrecallDS@amneal.com or call the company at 833-582-0812, Monday through Friday, 8 a.m. to 5 p.m., Eastern time, for more information.
To report any problems with Amneal’s Metformin, go to the FDA’s MedWatch site or call 800-332-1088 to request a reporting form. Also, contact Amneal by emailing DrugSafety@amneal.com or calling 877-835-5472, Monday through Friday, 8 a.m. to 6 p.m., Eastern time.
Retailers with Amneal’s Metformin should email Inmar at Rxcalls@inmar.com or call 855-532-1851, Monday through Friday, 8 a.m. to 5 p.m., Eastern time, to set up a return of the product.
This story was originally published June 2, 2020 at 6:41 PM with the headline "As expected, more diabetes medicine recalled because too much of a carcinogen was found."
