Diabetes medicine recalled for having too much of a carcinogen. More recalls are likely
Apotex has recalled all its Metformin Hydrochloride Extended-Release Tablets 500 mg in the United States for too much of carcinogen NDMA, the same “impurity” that got all the Zantac yanked earlier this year.
And this could be the first of several recalls of metformin, a drug that helps control the blood sugar of those with Type 2 diabetes. The FDA announced Thursday night that its testing found too much NDMA (N-Nitrosodimethylamine) in multiple lots of extended release metformin after a private laboratory found too much in even more lots.
“The agency is in contact with five firms to recommend they voluntarily recall their products,” the FDA stated. “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 FDA is continuing to work closely with manufacturers to ensure appropriate testing.”
Apotex, which has a base in Weston, says “only limited product” remains on the U.S. market after the company stopped selling Metformin Hydrochloride Extended-Release Tablets 500 mg here in February 2019. For those about to check their cabinets, the tablets come in 100-count bottles and NDC No. 60505-0260-1.
Wholesale sellers, distributors and retail sellers with the drug need to quarantine it. Customers who bought from Apotex directly can call Inmar Rx Solutions, which is handling this recall for Apotex, at 888-985-9014, option No. 1, Monday through Friday, 9 a.m. to 5 p.m., Eastern time.
If you’re a patient with a question about this recall, call Apotex at 800-706-5575, Monday through Friday, 8:30 a.m. to 5 p.m., Eastern time or email UScustomerservice@Apotex.com.
If you want to report a bad experience with a drug to the FDA, either go to the Adverse Event Reporting section of the website or call 800-332-1088.
This story was originally published May 29, 2020 at 6:57 AM with the headline "Diabetes medicine recalled for having too much of a carcinogen. More recalls are likely."
