Recalls / Class II
Class IID-1351-2020
Product
amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05
- Affected lot / code info
- HF06618A 6/30/2020 HF06718A 6/30/2020
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recalling firm
- Firm
- Amneal Pharmaceuticals of New York, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, N/A, Brookhaven, New York 11719-9509
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-05-29
- FDA classified
- 2020-06-25
- Posted by FDA
- 2020-07-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1351-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.