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 January 20, 2021. It was issued by Nostrum Laboratories Inc.
- Company
- Nostrum Laboratories Inc
- Recall Initiated
- January 4, 2021
- Posted
- January 20, 2021
- Recall Number
- D-0227-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6958 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
MET200501 07/2022
More recalls by Nostrum Laboratories Inc
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Feb 10, 2021 · Class II
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