FDA Recall D-0616-2020
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 Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Reason for recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall record
- Recall number
D-0616-2020- 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
Drug identification
- Brand name(s)
- RANITIDINE
- Generic name(s)
- RANITIDINE
- Manufacturer(s)
- Amneal Pharmaceuticals of New York LLC
- NDC(s)
53746-253, 53746-254- Route(s)
- ORAL
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.