FDA Recall D-1393-2020
Amneal Pharmaceuticals of New York, LLC · Brookhaven, NY
Class II Ongoing 2176 days on record
Product
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
Reason for recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall record
- Recall number
D-1393-2020- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2020-05-29
- Classified by FDA Center
- 2020-06-25
- FDA published
- 2020-07-01
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- 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.