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The FDA Issues Alert about Certain Extended-Release Metformin Products

Jun 01, 2020

On May 28, the U.S. Food and Drug Administration announced that the agency’s laboratory testing revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the FDA’s acceptable intake limit in several lots of the extended-release (ER) formulation of metformin. The FDA has been in contact with five firms to recommend they voluntarily recall their products. One company has already issued a voluntary nationwide recall on one lot of their ER formulation of metformin. Company recall notices will be posted on FDA’s website. This is the FDA’s “Recalls, Market Withdrawals, & Safety Alert site.” To find out about metformin (ER) recalls, enter “metformin” in the search bar.

ADCES is sharing this information with diabetes care and education specialists in an effort to keep our members informed of the FDA’s actions regarding this issue. Here is some key information regarding the potential recalls:

  1. Diabetes care and education specialists are encouraged to read the FDA’s alert and refer to their page for important updates.
  2. The issue only applies to certain extended-release formulations of metformin. The FDA testing has not shown NDMA in immediate-release (IR) metformin products.
  3. The FDA is advising that individuals should continue taking metformin tablets even after recalls occur, until they consult with their healthcare professional who can prescribe a replacement.
  4. Recall notices will be posted on the FDA’s website. This is the FDA’s “Recalls, Market Withdrawals, & Safety Alert site.” To find out about metformin (ER) recalls, enter “metformin” in the search bar.
  5. Please share this information within your respective organizations, practice, hospitals, clinics and provider colleagues.
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