Three Firms Recall Diabetes Drug

Apotex Inc., AvKARE Inc., and PD-Rx Pharmaceuticals Inc. are recalling metformin hydrochloride extended-release tablets after a US Food and Drug Administration (FDA) analysis identified an N-Nitrosodimethylamine (NDMA) impurity in the product that was above an acceptable level. The recalls are included in the June 24, 2020, FDA Enforcement Report. 

“Apotex was notified by the FDA that one lot of metformin hydrochloride extended-release tablets, USP, was tested and showed results for NDMA levels in excess of the acceptable daily intake limit and recommended recall of the one tested lot,” Apotex stated in a May 27, 2020, company announcement. “Apotex Corp has agreed to recall this 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 United States.” 

On May 27, 2020, Apotex voluntarily initiated its recall of all unexpired lots of metformin hydrochloride extended-release tablets, 500 mg, 100-count bottles (NDC 60505-260-1), distributed throughout in the United States.

AvKARE followed with a voluntary recall initiated June 4, 2020, for the following metformin products distributed nationwide:

• metformin hydrochloride extended-release tablets, 500 mg, 50-count bottles (NDC 5268-531-15) from lots 23537 (Exp. 6/30/20), 23613 (Exp. 6/30/20), 24083 (Exp. 6/30/20), 24291 (Exp. 6/30/20), 24725 (Exp. 6/30/20), 25637 (Exp. 6/30/21), and 25751 (Exp. 7/31/21);
• metformin hydrochloride extended-release tablets, 500 mg, 90-count bottles (NDC 42291-610-90) from lots 22073 (Exp. 6/30/20), 22460 (Exp. 7/31/20), 22539 (Exp. 9/30/20), 22540 (Exp. 9/30/20), 23299 (Exp. 1/31/21), 23300 (Exp. 1/31/21), 23484 (Exp. 1/31/21), 23917 (Exp. 3/31/21), 24477 (Exp. 6/30/21), 24514 (Exp. 6/30/21), 24945 (Exp. 8/31/21), 25591 (Exp. 10/31/21), 25590 (Exp. 10/31/21), 26004 (Exp. 11/30/21), 26322 (Exp. 1/31/21), 26339 (Exp. 2/28/22), 26520 (Exp. 1/31/22), and 26588 (Exp. 2/28/22);
• metformin hydrochloride extended-release tablets, 500 mg, 180-count bottles (NDC 42291-610-18) from lots 2222 (Exp. 6/30/20), 22541 (Exp. 9/30/20), 23293 (Exp. 1/31/21), 23475 (Exp. 1/31/21), 23658 (Exp. 3/31/21), 23979 (Exp. 3/31/21), 24303 (Exp. 6/30/21), 24476 (Exp. 6/30/21), 24550 (Exp. 6/30/21), 24804 (Exp. 7/31/21), 25380 (Exp. 8/31/21), 25592 (Exp. 10/31/21), 25736 (Exp. 10/31/21), 26005 (Exp. 11/30/21), 26006 (Exp. 10/31/21), 26326 (Exp. 1/31/22), 26483 (Exp. 2/28/22), 26484 (Exp. 2/28/22), and 26589 (Exp. 2/28/22);
•  metformin hydrochloride extended-release tablets, 500 mg, 360-count bottles (NDC 42291-610-36) from lots 22430 (Exp. 6/30/20), 22538 (Exp. 9/30/20), 22638 (Exp. 9/30/20), 22639 (Exp. 9/30/20), 23292 (Exp. 1/31/21), 23291 (Exp. 1/31/21), 23344 (Exp. 1/31/21), 23631 (Exp. 1/31/21), 23707 (Exp. 3/31/21), 23706 (Exp. 3/31/21), 24164 (Exp. 5/31/21), 24165 (Exp. 5/31/21), 24340 (Exp. 6/30/21), 24474 (Exp. 6/30/21), 24475 (Exp. 6/30/21), 24548 (Exp. 6/30/21), 24738 (Exp. 7/31/21), 24739 (Exp. 7/31/21), 24905 (Exp. 7/31/21), 24906 (Exp. 8/31/21), 25379 (Exp. 8/31/21), 25378 (Exp. 8/31/21), 25627 (Exp. 10/31/21), 25664 (Exp. 10/31/21), 26131 (Exp. 01/31/22), 26340 (Exp. 1/31/22), 26341 (Exp. 2/28/22), 26590 (Exp. 2/28/22), and 26591 (Exp. 2/28/22);
• metformin hydrochloride extended-release tablets, 500 mg, 1000-count bottles (NDC 42291-610-10) from lots HH01618A (Exp. 7/31/20), HH01718A (Exp. 7/31/20), HH01818A (Exp. 7/31/20), HH01918A (Exp. 7/31/20), HH2018A (Exp. 8/31/20), HH05018A (Exp. 8/31/20), HH05118A (Exp. 8/31/20), HH05218A (Exp. 8/31/20), HH05318A (Exp. 8/31/20), HH05418A (Exp. 8/31/20), HH05518A (Exp. 8/31/20), HH05618A (Exp. 8/31/20), HH05718A (Exp. 8/31/20), HH05818A (Exp. 8/31/20), HH05918A (Exp. 8/31/20), HH06018A (Exp. 8/31/20), HH06118A (Exp. 8/31/20), HH06218A (Exp. 8/31/20), HH06318A (Exp. 8/31/20), HH06418A (Exp. 8/31/20), HK09818A (Exp. 10/31/20), HK09918A (Exp. 10/31/20), HK10018A (Exp. 10/31/20), HK10118A (Exp. 10/31/20), HK1218A (Exp. 10/31/20), HK13618A (Exp. 11/30/20), HB10419A (Exp. 3/31/21), HC00119A (Exp. 3/31/21), HC0219A (Exp. 3/31/21), HC00319A (Exp. 3/31/21), HC00419A (Exp. 3/31/21), HD01619A (Exp. 4/30/21), HD01719A (Exp. 4/30/21), HD01819A (Exp. 4/30/21), HD01919A (Exp. 4/30/21), HD2019A (Exp. 4/30/21), HD09319B (Exp. 4/30/21), HD09419A (Exp. 4/30/21), HD09519A (Exp. 4/30/21), HD09619A (Exp. 4/30/21), HD09719A (Exp. 4/30/21), HD09819A (Exp. 4/30/21), HD09919A (Exp. 4/30/21), HE00919A (Exp. 4/30/21), HE01019A (Exp. 4/30/21), HE01119A (Exp. 4/30/21), HE09419A (Exp. 5/31/21), HE09519A (Exp. 5/31/21), HE13119A (Exp. 5/31/21), HE13219A (Exp. 5/31/21), HE13319A (Exp. 5/31/21), HE13419A (Exp. 5/31/21), HE13519A (Exp. 5/31/21), HE13619A (Exp. 5/31/21), HE13719A (Exp. 5/31/21), HE13819A (Exp. 5/31/21), HE13919A (Exp. 5/31/21), HE14019A (Exp. 5/31/21), HF01919A (Exp. 5/31/21), HF2019A (Exp. 5/31/21), HF2119A (Exp. 5/31/21), HG06019A (Exp. 7/31/21), HG06119A (Exp. 7/31/21), HG06219A (Exp. 7/31/21), HG06319A (Exp. 7/31/21), HG06419A (Exp. 7/31/21), HG06519A (Exp. 7/31/21), HG06619A (Exp. 7/31/21), HG06719A (Exp. 7/31/21), HG06819A (Exp. 7/31/21), HG06919A (Exp. 7/31/21), HH03419A (Exp. 8/31/21), HH03519A (Exp. 8/31/21), HH03619A (Exp. 8/31/21), HH03719A (Exp. 8/31/21), HH03819A (Exp. 8/31/21), HH03919A (Exp. 8/31/21), HH04019A (Exp. 8/31/21), HH04119A (Exp. 8/31/21), HH04219A (Exp. 8/31/21), HH04319A (Exp. 8/31/21), HH08319A (Exp. 8/31/21), HH08419A (Exp. 8/31/21), HH08519A (Exp. 8/31/21), HH08619A (Exp. 8/31/21), HH08719A (Exp. 8/31/21), HH08819A (Exp. 8/31/21), HH08919A (Exp. 8/31/21), HH09019A (Exp. 8/31/21), HH09119A (Exp. 8/31/21), HH09219A (Exp. 8/31/21), HL01119B (Exp. 11/30/21), HL01219A (Exp. 11/30/21), HA00520A (Exp. 1/31/22), HA00620A (Exp. 1/31/22), HA00720A (Exp. 1/31/22), HA00820A (Exp. 1/31/22), HA00920A (Exp. 1/31/22), HA120A (Exp. 1/31/22), HA1120A (Exp. 1/31/22), HA1220A (Exp. 1/31/22), HB05720A (Exp. 2/28/22), HB05820A (Exp. 2/28/22), HB05920A (Exp. 2/28/22), HB0620A (Exp. 2/28/22), HB06120A (Exp. 2/28/22), HB06220A (Exp. 2/28/22), HB06320A (Exp. 2/28/22), HB06420A (Exp. 2/28/22), HB06520A (Exp. 2/28/22), and HB06620A (Exp. 2/28/22); 
• metformin hydrochloride extended-release tablets, 750 mg, 90-count bottles (NDC 42291-611-90) from lots 23069 (Exp. 11/30/20), 24571 (Exp. 5/31/21), 25310 (Exp. 7/31/21), and 26391 (Exp. 1/31/22); 
• metformin hydrochloride extended-release tablets, 750 mg, 180-count bottles (NDC 42291-611-18) from lots 22542 (Exp. 6/30/20), 23345 (Exp. 11/30/20), 24032 (Exp. 3/31/21), 24624 (Exp. 7/31/21), 24631 (Exp. 5/31/21), 25381 (Exp. 8/31/21), 25907 (Exp. 10/31/21), and 26478 (Exp. 1/31/22); and
• metformin hydrochloride extended-release tablets, 750 mg, 500-count bottles (NDC 42291-611-50) from lots 22348 (Exp. 6/30/20), 22405 (Exp. 6/30/20), 22406 (Exp. 6/30/20), 22740 (Exp. 6/30/20), 23346 (Exp. 11/30/20), 23926 (Exp. 3/31/21), 24364 (Exp. 5/31/21), 25014 (Exp. 7/31/21), 25334 (Exp. 9/30/21), 25906 (Exp. 10/31/21), and 26392 (Exp. 1/31/22).

On June 5, 2020, PD-Rx Pharmaceuticals Inc. initiated its voluntary recall of the following metformin products, which were distributed throughout the United States:

• metformin hydrochloride extended-release tablets, 500 mg, 30-count bottles (NDC 43063-428-30) from lots D19C80, F19C39, H19A55, H19D56, and I18E0 (Exp. 6/30/20);
• metformin hydrochloride extended-release tablets, 500 mg, 60-count bottles (NDC 43063-428-60) from lots D19A66, E19C15, and F19D60 (Exp. 6/30/20);
• metformin hydrochloride extended-release tablets, 500 mg, 90-count bottles (NDC 43063-428-90) from lots E19D32, J18B83, C19D25, C19E78, D19C60, D19D64, F19B27, G19A31, G19C41, and I19A56 (Exp. 6/30/20);
• metformin hydrochloride extended-release tablets, 500 mg, 120-count bottles (NDC 43063-428-98) from lots E19C11, F19E33, and I18E07 Exp. (6/30/20);
• metformin hydrochloride extended-release tablets, 500 mg, 180-count bottles (NDC 43063-428-93) from lots D19D56, F19A51, H19A09, H19A81, H19B16, H19B77, H19C28, and I18F43 (Exp. 6/30/20); and
• metformin hydrochloride extended-release tablets, 500 mg, 500-count bottles (NDC 53746-0178-05) from lots HF06618A and HF06718A (Exp. 6/30/20).

On June 12, 2020, the FDA designated each of the recalls Class II. Under Class II recalls, use of the product could 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