Class II
Ongoing
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
This recall is currently active, issued November 11, 2020. It was issued by Nostrum Laboratories Inc.
- Company
- Nostrum Laboratories Inc
- Recall Initiated
- October 23, 2020
- Posted
- November 11, 2020
- Recall Number
- D-0068-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 20,872 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
MET100201, MET100401 EXP 05/2022
More recalls by Nostrum Laboratories Inc
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Feb 10, 2021 · Class II
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manu...
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