The U.S. Food and Drug Administration has asked some pharmaceutical companies to voluntarily recall extended-release metformin, a popular drug used to control high blood sugar in people with Type 2 diabetes, because it may include a carcinogen.
On May 28, the FDA said laboratory testing “revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit” in the extended-release form of the drug.
“The FDA is continuing to work closely with manufacturers to ensure appropriate testing. Assessments are underway to determine whether metformin ER recalls will result in shortages and the agency will work closely with manufacturers to prevent or reduce any impact of shortages.”
NDMA is a probable human carcinogen, meaning it could cause cancer.
The FDA has posted recalls from Teva Pharmaceuticals, Marksans Pharma Limited, Apotox Corp. and Amneal Pharmaceuticals.
Teva Pharmaceuticals USA, Inc., recalled 14 lots of 500-mg and 750-mg metformin in 100 and 1,000 count bottles.
The details of that Teva recall are:
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.
- 100-count bottles, NDC number 62037-571-01 - lot number 1329548A and expiration June 2020; lot number 1338302M, expiration October 2020; lot number 1348968M, expiration October 2020; lot number 1348969M, expiration November 2020; lot number 1348970M, expiration October 2020; and lot number 1376339M, expiration September 2021.
- 1,000-count bottles, NDC number 62037-571-10 – lot number 1323460M, expiration June 2020; lot number 1330919M, expiration June 2020; lot number 1338300A, expiration October 2020; lot number 1341135M, expiration December 2020; and lot number 1391828M, expiration November 2021.
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.
- 100-count bottles, NDC number 62037-577-01 – lot number 1333338M, expiration August 2020; and 1333339A, expiration August 2020.
- 1,000-count bottles, NDC number 62037-577-10 – lot number 1354471A, expiration February 2021.
For more information, call Teva at 888-838-2872, option 3 then option 4, 9 a.m. to 5 p.m. weekdays ET or send an email to druginfo@tevapharm.com.
Marksans Pharma Limited, India, also recalled its metformin hydrochloride extended-release tablets.
- That recall is for 500-mg pills, lot number XP9004 with an expiration date of December 2020.
That metformin was distributed by Time-Cap Labs in New York. For more information, conact Irene McGregor at Time-Cap at 631-753-9090, ext. 160, 8 a.m. to 5 p.m. ET weekdays or send an email to imcgregor@timecaplabs.com.
Apotox Corp. recalled its 500-mg metformin with an NDC number of 60505-0260-1.
Amneal Pharmaceuticals recalled its 500-mg and 750-mg tablets of metformin.
- NDC numbers for the 500-mg product are 53746-178-01 (100 count bottle), 53746-178-05 (500 count bottle), 53746-178-10 (1,000 count bottle), 53746-178-90 (90 count bottles), 53746-178-bulk (bulk box), 65162-178-09 (90 count bottles), 65162-178-10 (100 count bottles), 65162-178-11 (1,000 count bottles) and 65162-178-50 (500 county bottles).
- NDC numbers for the 750-mg product are 53746-179-01 (100 count bottles), 53746-179-bulk (bulk box) and 65162-179-10 (100 count bottles).
For more information, call Amneal at 833-582-0812, 8 a.m. to 5 p.m. ET weekdays or send an email to amnealproductrecallds@amneal.com.
The FDA is advising people who take metformin to talk to their health care providers before discontinuing use of the drug.
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Teva Pharmaceuticals USA is one of multiple companies recalling metformin, a drug used to control high blood sugar in people who have Type 2 diabetes because it contains an ingredient that may cause cancer. (Provided photo)
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