FDA Recall D-0614-2020
Amneal Pharmaceuticals, Inc. · Brookhaven, NY
Class II Ongoing 2365 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0614-2020- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Product was distributed throughout the United States.
- Recall initiated
- 2019-11-22
- Classified by FDA Center
- 2019-12-09
- FDA published
- 2019-12-18
- Recalling firm
- Amneal Pharmaceuticals, Inc.
- Firm location
- Brookhaven, NY
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.