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More Firms Initiate Recalls for Diabetes Drug


July 24, 2020

Granules Pharmaceuticals Inc. and Lupin Pharmaceuticals Inc. joined the growing list of firms voluntarily recalling metformin hydrochloride extended-release tablets. The recalls were included in the July 22, 2020, US Food and Drug Administration (FDA) Enforcement Report, which cites an FDA analysis that detected an N-Nitrosodimethylamine (NDMA) impurity above an acceptable level as the reason behind the recalls. 

On July 3, 2020, Granules Pharmaceuticals initiated recalls for the following metformin products, which were distributed throughout the United States:

  • 750-mg metformin hydrochloride extended-release tablets in 100-count bottles (NDC 70010-492-01) from lots 4920003A (Exp. 5/21), 4920004A (Exp. 6/21), 4920005A (Exp. 6/21), 4920009A (Exp. 11/21), 4920010A (Exp. 5/22), 4920011A (Exp. 6/22), 4920012A (Exp. 6/22), 4920013A (Exp. 7/22), 4920014A (Exp. 7/22), 4920015A (Exp. 8/22), and 4920016A (Exp. 1/23); and
  • 750-mg metformin hydrochloride extended-release tablets in 500-count bottles (NDC 70010-492-05) from lot 4920005B (Exp. 6/21). 

On July 7, 2020, Lupin Pharmaceuticals initiated recalls for the following metformin products, which were distributed throughout the United States:

  • 500-mg metformin hydrochloride extended-release tablets in 60-count bottles (NDC 68180-336-07) from lots G808293 (Exp. 8/20), G808284 (Exp. 8/20), G808285 (Exp. 8/20), G808343 (Exp. 8/20), G901201 (Exp. 12/20), G901202 (Exp. 12/20), G906915 (Exp. 7/21), G906913 (Exp. 7/21), G906914 (Exp. 7/21), G002135 (Exp. 7/22), and G002849 (Exp. 2/22);
  • 500-mg metformin hydrochloride extended-release tablets in 100-count bottles (NDC 68180-338-01) from lots G808201 (Exp. 8/20), G808202 (Exp. 8/20), G808200 (Exp. 8/20), G900935 (Exp. 12/20), G901311 (Exp. 12/20), G900957 (Exp. 12/20), G900958 (Exp. 12/20), G901006 (Exp. 12/20), G904803 (Exp. 5/21), G904804 (Exp. 5/21), G906551 (Exp. 7/21), G906552 (Exp. 7/21), G907375 (Exp. 8/21), G908605 (Exp. 10/21), G908604 (Exp. 10/21), G002108 (Exp. 1/22), G002109 (Exp. 1/22), G002559 (Exp. 2/22), and G002560 (Exp. 2/22);
  • 1000-mg metformin hydrochloride extended-release tablets in 60-count bottles (NDC 68180-337-07) from lots G807619 (Exp. 7/20), G807620 (Exp. 7/20), G807733 (Exp. 7/20), G807734 (Exp. 7/20), G807735 (Exp. 7/20), G807445 (Exp. 7/20), G807617 (Exp. 7/20), G807618 (Exp. 7/20), G808042 (Exp. 7/20), G808043 (Exp. 7/20), G807349 (Exp. 7/20), G807350 (Exp. 7/20), G807444 (Exp. 7/20), G807507 (Exp. 7/20), G807508 (Exp. 7/20), G807314 (Exp. 7/20), G807316 (Exp. 7/20), G807325 (Exp. 7/20), G807348 (Exp. 7/20), G807616 (Exp. 7/20), G807312 (Exp. 7/20), G807313 (Exp. 7/20), G807315 (Exp. 7/20), G808374 (Exp. 8/20), G808427 (Exp. 8/20), G808373 (Exp. 8/20), G808426 (Exp. 8/20), G900057 (Exp. 10/20), G900058 (Exp. 10/20), G900059 (Exp. 10/20), G900060 (Exp. 10/20), G900061 (Exp. 10/20), G900062 (Exp. 10/20), G900106 (Exp. 10/20), G900140 (Exp. 10/20), G900141 (Exp. 10/20), G900152 (Exp. 10/20), G809596 (Exp. 10/20), G809598 (Exp. 10/20), G810182 (Exp. 10/20), G810183 (Exp. 10/20), G810184 (Exp. 10/20), G810185 (Exp. 10/20), G810186 (Exp. 10/20), G810187 (Exp. 10/20), G810188 (Exp. 10/20), G810189 (Exp. 10/20), G809554 (Exp. 10/20), G809556 (Exp. 10/20), G809557 (Exp. 10/20), G809558 (Exp. 10/20), G809559 (Exp. 10/20), G809548 (Exp. 10/20), G809549 (Exp. 10/20), G809550 (Exp. 10/20), G809551 (Exp. 10/20), G809552 (Exp. 10/20), G809553 (Exp. 10/20), G809555 (Exp. 10/20), G901004 (Exp. 12/20), G901005 (Exp. 12/20), G901053 (Exp. 12/20), G901002 (Exp. 12/20), G901003 (Exp. 12/20), G903182 (Exp. 3/21), G903183 (Exp. 3/21), G903236 (Exp. 3/21), G903237 (Exp. 3/21), G903238 (Exp. 3/21), G903155 (Exp. 3/21), G903156 (Exp. 3/21), G903157 (Exp. 3/21), G903158 (Exp. 3/21), G903159 (Exp. 3/21), G903178 (Exp. 3/21), G903179 (Exp. 3/21), G903180 (Exp. 3/21), G903181 (Exp. 3/21), G903239 (Exp. 3/21), G001837 (Exp. 1/22), G001860 (Exp. 1/22), G001861 (Exp. 1/22), G001905 (Exp. 1/22), G001933 (Exp. 1/22), G001934 (Exp. 1/22), G001763 (Exp. 1/22), G001764 (Exp. 1/22), G001765 (Exp. 1/22), G001766 (Exp. 1/22), G001767 (Exp. 1/22), G001795 (Exp. 1/22), and G001836 (Exp. 1/22); and
  • 1000-mg metformin hydrochloride extended-release tablets in 90-count bottles (NDC 68180-339-09) from lots G807093 (Exp. 7/20), G807147 (Exp. 7/20), G807208 (Exp. 7/20), G807479 (Exp. 7/20), G807480 (Exp. 7/20), G807830 (Exp. 7/20), G807092 (Exp. 7/20), G809471 (Exp. 7/20), G808155 (Exp. 8/20), G808074 (Exp. 8/20), G808115 (Exp. 8/20), G900231 (Exp. 11/20), G900232 (Exp. 11/20), G903277 (Exp. 3/21), G903278 (Exp. 3/21), G903279 (Exp. 3/21), G903280 (Exp. 3/21), G903281 (Exp. 3/21), G903818 (Exp. 4/21), G904048 (Exp. 4/21), G904164 (Exp. 4/21), G906548 (Exp. 7/21), G907239 (Exp. 8/21), G907255 (Exp. 8/21), G907256 (Exp. 8/21), G907263 (Exp. 8/21), G001802 (Exp. 1/22), G001804 (Exp. 1/22), G001803 (Exp. 1/22), G001805 (Exp. 1/22), G001806 (Exp. 1/22), G001807 (Exp. 1/22), G001808 (Exp. 1/22), G808154 (Exp. 8/20), G900227 (Exp. 11/20), G900228 (Exp. 11/20), G900229 (Exp. 11/20), G900230 (Exp. 11/20), G906549 (Exp. 7/21), G906550 (Exp. 7/21), G906547 (Exp. 7/21), G907279 (Exp. 8/21), G907364 (Exp. 8/21), G001809 (Exp. 1/22), G001801 (Exp. 1/22), G002563 (Exp. 2/22), and G002564 (Exp. 2/22). 

On July 14, 2020, the FDA designated the Granules Pharmaceuticals and Lupin Pharmaceuticals recalls Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists. 

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

Jolynn Tumolo

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