FDA recall D-0616-2020
Amneal Pharmaceuticals, Inc. · Class II · drug
Product
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Reason for recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Distribution
Product was distributed throughout the United States.
Key facts
- Status
- Ongoing
- Initiation date
- 2019-11-22
- Report date
- 2019-12-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Brookhaven, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0616-2020