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Multiple Firms Issue New Recalls for Diabetes Drug


November 13, 2020

New metformin recalls from five firms were included in the November 11, 2020, US Food and Drug Administration (FDA) Enforcement Report. All of the firms cited the detection of an N-Nitrosodimethylamine (NDMA) impurity as the reason for the voluntary recalls. 

“NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests,” explained a company announcement from Marksans Pharma Limited. “NDMA is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables. Marksans Pharma Limited has not received any reports of adverse events that have been related to this recall.” 

Marksans Pharma Limited is recalling the following metformin products, which were distributed throughout the United States by Time-Cap Labs Inc:

  • 90-count metformin hydrochloride extended-release tablets, 500 mg (NDC 49483-623-09), from lots E072F, E074F, and E076F (Exp. 10/20); D096F, H029F, H031F, XP8276, and XP8289 (Exp. 11/20); L007F, J022F, and H039F (Exp. 12/20); J092F (Exp. 1/21); L055F (Exp. 6/21); K079F (Exp. 7/21); A002G, A003G, and A007G (Exp. 8/21); A49001 (Exp. 11/21); A40001, A40003, and A40005 (Exp. 12/21); A40009 (Exp. 2/22); A40010, XP0036, and A40013 (Exp. 3/22); and A40015 (Exp. 4/22);
  • 100-count metformin hydrochloride extended-release tablets, 500 mg (NDC 49483-623-01), from lots XP8260 (Exp. 10/20); XP0010 and XP0016 (Exp. 12/21); and XP0046 (Exp. 4/22);
  • 500-count metformin hydrochloride extended-release tablets, 500 mg (NDC 49483-623-50), from lots E037F and G011F (Exp. 10/20); F001F (Exp. 11/20); H041F and L009F (Exp. 12/20); K051F (Exp. 6/21); A115G and A010G (Exp. 9/21); A40006, A40007, and A40008 (Exp. 1/22); A40011 (Exp. 3/22); and A40016 and A40018 (Exp. 4/22);
  • 1000-count metformin hydrochloride extended-release tablets, 500 mg (NDC 49483-623-10), from lots D086F (Exp. 10/20); G012F (Exp. 11/20); L008F (Exp. 12/20); K042F (Exp. 2/21); M001F (Exp. 7/21); A009G (Exp. 9/21); A40002 and A40004 (Exp. 12/21); A40012 (Exp. 3/22); and A40014 and A40017 (Exp. 4/22); and
  • 100-count metformin hydrochloride extended-release tablets, 750 mg (NDC 49483-624-01), from lots M125E (Exp. 10/20); D001F and C084F (Exp. 11/20); F073F and E063F (Exp. 1/21); F072F (Exp. 3/21); J002F and J087F (Exp. 4/21); K080F and L056F (Exp. 6/21); M046F (Exp. 7/21); 9R9001 (Exp. 10/21); 9R9002 (Exp. 11/21); 9R0001 and 9R0002 (Exp. 12/21); 9R0003, XR0016, 9R0004, and 9R0005 (Exp. 3/22); and 9R0006 and 9R0007 (Exp. 4/22). 

Denton Pharma Inc. is recalling the following metformin products, which were repackaged by Northwind Pharmaceuticals and distributed throughout the United States:

  • 30-count metformin hydrochloride extended-release tablets, 500 mg (NDC 70934-309-30), from lots N107051905 (Exp. 10/31/20); and N107052002 and N107052005 (Exp. 9/30/21);
  • 60-count metformin hydrochloride extended-release tablets, 500 mg (NDC 70934-309-60), from lots N107051907 (Exp. 10/31/20); N107052001 (Exp. 6/30/21); and N107052010, N107052008, and N107052004 (Exp. 9/30/21);
  • 90-count metformin hydrochloride extended-release tablets, 500 mg (NDC 70934-309-90), from lots C107051908 (Exp. 10/31/20); C107052002 and C107051909 (Exp. 6/30/21), C107052001 (Exp. 12/31/20); and C107052004, N107052006, N107052007, N107052009, N107052011, and N107052012 (Exp. 9/30/21);
  • 120-count metformin hydrochloride extended-release tablets, 500 mg (NDC 70934-309-98), from lots C107051907, N107051904, and N107051906 (Exp. 10/31/20); C107051910 (Exp. 6/30/21); and C107052003, C107052005, and N107052003 (Exp. 9/30/21); and
  • 30-count metformin hydrochloride extended-release tablets, 750 mg (NDC 70934-334-30), from lots N107411901, N107411903, N107411904, N107411905, and N107411906 (Exp. 11/30/20); N107411907 and N107412001 (Exp. 4/30/21); N107412002 and N107412004 (Exp. 11/30/21); and N107412003 (Exp. 7/31/21). 

PD-Rx Pharmaceuticals Inc. is recalling the following metformin products, which were distributed in Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Minnesota, North Carolina, New York, Oklahoma, Oregon, and Wisconsin:

  • 30-count metformin hydrochloride extended-release tablets, 500 mg (NDC 72789-009-30), from lots B20D23 and B20D67 (Exp. 7/31/21), and C20D55 (Exp. 12/31/21);
  • 60-count metformin hydrochloride extended-release tablets, 500 mg (NDC 72789-009-60), from lots A20D92, A20F59, and B20C16 (Exp. 7/31/21); C20D63, D20A45, and D20C80 (Exp. 12/31/21); and G20D46 and I20C57 (Exp. 4/30/22);
  • 90-count metformin hydrochloride extended-release tablets, 500 mg (NDC 72789-009-90), from lots A20D90, A20E77, A20F69, and B20F43 (Exp. 7/31/21); C20B14 and D20A41 (Exp. 12/31/21), and I20D94, I20E56, and J20A28 (Exp. 04/30/22);
  • 180-count metformin hydrochloride extended-release tablets, 500 mg (NDC 72789-009-93), from lots B20B96 (Exp. 7/31/21), C20C28, C20E58, and D20B17 (Exp. 12/31/21), and G20D91 (Exp. 4/30/22);
  • 30-count metformin hydrochloride extended-release tablets, 750 mg (NDC 43063-902-30), from lots A20A97 and B20D25 (Exp. 4/30/21); B20D69, C20B95, C20D60, and E20A50 (Exp. 7/31/21); E20D37 and E20D73 (Exp. 3/31/22); and J19F04 (Exp. 1/31/21); and
  • 60-count metformin hydrochloride extended-release tablets, 750 mg (NDC 43063-902-60), from lots C20C15 (Exp. 7/31/21); F20A14 (Exp. 3/31/22), and L19C15 (Exp. 4/30/21). 

Nostrum Laboratories Inc. is recalling the following metformin products, which were distributed throughout the United States:

  • 100-count metformin hydrochloride extended-release tablets, 500 mg (NDC 29033-055-01), from lots MET100201 and MET100401 (Exp. 5/22); and
  • 100-count metformin hydrochloride extended-release tablets, 750 mg (NDC 29033-056-01), from lots MET200101 and MET200301 (Exp. 5/22).

Direct Rx is recalling 90-count metformin hydrochloride extended-release tablets, 500 mg (NDC 72189-064-90), from lots 04DE1902 and 11DE1908 (Exp. 6/30/21), which were distributed in Florida.  

All of the recalls were voluntarily initiated in October 2020. In early November 2020, the FDA designated the recalls Class II, communicating use of the recalled medications may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm. 

Metformin is a prescription medication used to help control blood sugar levels in people with type 2 diabetes.

Jolynn Tumolo

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