FDAFDA · Food and drugs·Recall number D-0392-2022
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Published February 2, 2022 · Recall initiated: December 27, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- VIONA PHARMACEUTICALS INC
- Distributor
- Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
- Lot
- M008130 06/2022, M008131 06/2022, M008132 06/2022, M008133 06/2022, M010080 07/2022, M010081 07/2022, M011029 08/2022, M011030 08/2022, M011031 08/2022, M011032 08/2022, M011304 08/2022, M013394 09/2022, M013395 09/2022, M013396 09/2022, M013966 09/2022, M013967 09/2022, M100831 12/2022, M100832 12/2022, M100833 01/2023, M100834 01/2023, M101267 01/2023, M102718 01/2023, M102719 01/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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