FDAFDA · Food and drugs·Recall number D-1354-2020
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
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
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Distributor
- Nationwide
- Lot
- HA01520A 1/31/2021 HA01620A 1/31/2021 HG01719A 7/31/2020 HG01819A 7/31/2020 HH09319A 8/31/2020 HH09419A 9/30/2020 HK07619A 10/31/2020 HK07719A 10/31/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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