Drug product
Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-490-12 UPC 3 16729 49012 2
D-0383-2023
Product summary
- Event
- Event 91657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37,790 bottles
- Official record key
drug-enforcement:D-0383-2023
Official wording
Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Code information: Batches: P2101480, Exp. Date 2/28/2023; P2102579, P2102596, Exp. Date 4/30/2023; P2104711, P2104707, Exp. Date 6/30/2023; P2200771, P2200829, P2200795, Exp. Date 12/31/2023; P2202608, Exp. Date 4/30/2025; P2203492, P2203463, Exp. Date 5/31/2025; P2205373, P2205412, Exp. Date 8/31/2025;
Distribution pattern: United States including Puerto Rico and Canada
Derived failure modes
-
Manufacturing or process control
CGMP Deviations