Recalls / Class II
Class IID-0068-2021
Product
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
- Affected lot / code info
- MET100201, MET100401 EXP 05/2022
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
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1800 N Topping Ave, N/A, Kansas City, Missouri 64120-1228
Distribution
- Quantity
- 20,872 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-10-23
- FDA classified
- 2020-11-05
- Posted by FDA
- 2020-11-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0068-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.