D-0249-2021 Class II Ongoing
FDA drug recall D-0249-2021 was initiated by Nostrum Laboratories Inc on Jan 25, 2021 and is designated Class II. Reason for recall: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. The recall status is ongoing. Affected quantity: 7071 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 10, 2021
- Initiation Date
- Jan 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7071 bottles
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.
Distribution pattern
Nationwide
Code information
Lot MET200601, 07/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0249-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026