FDAFDA · Food and drugs·Recall number D-1344-2020
amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08907 NDC 65162-178-09
Published July 1, 2020 · Recall initiated: May 29, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Distributor
- Nationwide
- UPC
- 0365162178104
- Lot
- AM190123A 1/31/2021 AM190193A 1/31/2021 AM190194A 1/31/2021 AM190195A 1/31/2021 AM190196A 1/31/2021 AM190197A 1/31/2021 AM190198A 1/31/2021 AM190199A 1/31/2021 AM190200A 2/28/2021 AM190201A 2/28/2021 AM190202A 2/28/2021 AM190269A 2/28/2021 AM190270A 2/28/2021 AM190271A 2/28/2021 AM190272A 2/28/2021 AM190289A 2/28/2021 AM190290A 2/28/2021 AM190291A 2/28/2021 AM190292A 2/28/2021 AM190293A 2/28/2021 AM190294A 2/28/2021 AM190549A 4/30/2021 AM190550A 4/30/2021 AM190551A 4/30/2021 AM190552A 4/30/2021 AM190553A 4/30/2021 AM190554A 4/30/2021 AM190555A 5/31/2021 AM190556A 5/31/2021 AM190586A 5/31/2021 AM190587A 5/31/2021 AM190588A 5/31/2021 AM190589A 5/31/2021 AM190590A 5/31/2021 AM190605A 5/31/2021 AM190673A 6/30/2021 AM190707A 6/30/2021 AM190708A 6/30/2021 AM190709A 6/30/2021 AM190710A 6/30/2021 AM190714C 6/30/2021 AM190751C 6/30/2021 AM190752C 6/30/2021 AM190753A 8/31/2021 AM190754A 8/31/2021 AM190755A 8/31/2021 AM190756A 8/31/2021 AM190757A 8/31/2021 AM190929A 8/31/2021 AM190930A 8/31/2021 AM190931A 8/31/2021 AM190932A 8/31/2021 AM190933A 8/31/2021 AM190995A 8/31/2021 AM191000A 8/31/2021 AM191001A 8/31/2021 AM191002A 8/31/2021 AM191003A 8/31/2021 AM191034A 9/30/2021 AM191035A 9/30/2021 AM191036A 9/30/2021 AM191037A 9/30/2021 AM191038A 9/30/2021 AM191039A 9/30/2021 AM191086A 9/30/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.