Recalls / Class II
Class IID-0614-2020
Product
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
- Affected lot / code info
- 06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm
- Firm
- Amneal Pharmaceuticals, Inc.
- 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
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2019-11-22
- FDA classified
- 2019-12-09
- Posted by FDA
- 2019-12-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0614-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.