D-0067-2021 Class II Ongoing
FDA drug recall D-0067-2021 was initiated by Nostrum Laboratories Inc on Oct 23, 2020 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: 12,967 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 11, 2020
- Initiation Date
- Oct 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,967 bottles
Product description
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, 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
MET200101, MET200301 EXP 05/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0067-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026