More companies recall a Type 2 diabetes drug. It could contain too much of a carcinogen
Three makers of Type 2 diabetes drug Metformin announced recalls Friday, the U.S. Food & Drug Administration reported.
The reason for the voluntary recalls: the U.S. Food & Drug Administration determined that these medications might have too much NDMA, a substance that can cause cancer in certain amounts.
The three drug manufacturers
Apotex, which is is produced by a company headquartered in Weston in Broward County, is expanding its recently announced retail level recall of its Type 2 diabetes drug Metformin Hydrochloride Extended-Release Tablets, USP 500mg, to consumer level.
In addition to Apotex, Teva Pharmaceuticals USA, Inc. recalled 14 lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1,000 count bottles, in the United States. Teva has joint headquarters in New Jersey and Israel.
And Marksans Pharma Limited, headquartered in India, recalled its Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004. These pills, with an expiration date of December 2020, were distributed by Time-Cap Labs from Farmingdale, New York, nationwide to wholesalers that distribute to pharmacies.
Patients who take these medication should contact their pharmacy to return the pills, the FDA says. They are also advised to consult their doctor for medical advice on how to continue their therapy to control blood sugar levels.
According to the FDA, Apotex Corp agreed to recall its lot, “and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the U.S. “
Apotex stopped selling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, domestically in February and there should only be limited product on the market. Apotex has not received any reports of adverse events related to the drug’s use so far, the FDA said.
What to look for on the labels
On the Apotex 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 Marsans label for its bottles of 100 tablets at 500 mg. Lot XP9004.
And the Teva label for its bottle of 100 tablets at 500 mg. Lot numbers: 1329548A, 1338302M, 1348968M, 1348970M, 1376339M, 1323460M, 1330919M, 1338300A, 1321135M,1391828M, 133338M, 133339A, 1354471A.
Teva’s label for its 750 mg bottle is similar. The company also recalled its 1,000 tablet bottles.
How to return the medication
▪ Consumers who bought Apotex Metformin can email UScustomerservice@Apotex.com or call the company at 800-706-5575, Monday through Friday, 8:30 a.m. to 5 p.m., Eastern time, for more information.
▪ For consumers concerning Marksans, you can call Irene McGregor, vice president of regulatory affairs for Time-Cap Labs, at 631-753-9090; ext. 160, Monday-Friday 8 a.m.-5 p.m. or e-mail address imcgregor@timecaplabs.com.
▪ For Teva products, you can contact the company’s medical information line at 888-838-2872, choose option 3, then, option 4. Live calls are received Monday-Friday, 9 a.m. to 5 p.m. with voicemail available 24 hours daily or by email at druginfo@tevapharm.com.
▪ 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.
Report problems
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 6, 2020 at 10:42 AM with the headline "More companies recall a Type 2 diabetes drug. It could contain too much of a carcinogen."
