FDA recall D-0614-2020
Amneal Pharmaceuticals, Inc. · Class II · drug
Product
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
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-0614-2020