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
Reported: February 10, 2021 Initiated: January 25, 2021 #D-0249-2021
Product Description
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
Reason for Recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Details
- Recalling Firm
- Nostrum Laboratories Inc
- Units Affected
- 7071 bottles
- Distribution
- Nationwide
- Location
- Kansas City, MO
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Nostrum Laboratories Inc. Units affected: 7071 bottles.
Why was this product recalled? ▼
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 10, 2021. Severity: Moderate. Recall number: D-0249-2021.
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