Class II
Ongoing
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01
This recall is currently active, issued February 10, 2021. It was issued by Nostrum Laboratories Inc.
- Company
- Nostrum Laboratories Inc
- Recall Initiated
- January 25, 2021
- Posted
- February 10, 2021
- Recall Number
- D-0249-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 7071 bottles
- Firm Location
- Kansas City, MO, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Distribution
Nationwide
Lot / Code Info
Lot MET200601, 07/2022
More recalls by Nostrum Laboratories Inc
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manu...
Jan 20, 2021 · Class II
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactur...
Nov 11, 2020 · Class II
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