Recalls / Class II
Class IID-0227-2021
Product
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
- Affected lot / code info
- MET200501 07/2022
Why it was recalled
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recalling firm
- Firm
- Nostrum Laboratories Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1800 N Topping Ave, N/A, Kansas City, Missouri 64120-1228
Distribution
- Quantity
- 6958 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-01-04
- FDA classified
- 2021-01-14
- Posted by FDA
- 2021-01-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0227-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.