Drug product
Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100-count bottle, NDC 16729-282-01, UPC 3 16729 28201 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
D-0369-2023
Product summary
- Event
- Event 91657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 170,448 bottles
- Official record key
drug-enforcement:D-0369-2023
Official wording
Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Code information: Batches: a) P2100787, P2100788, Exp. Date 1/31/2024; P2104736, Exp. Date 6/30/2024; P2105492, Exp. Date 8/31/2024; P2107172, P2107175, Exp. Date 10/31/2024; P2203043, Exp. Date 5/31/2025; b) P2104086 Exp. Date 6/30/2024, P2205370 Exp. 8/31/2025;
Distribution pattern: United States including Puerto Rico and Canada
Derived failure modes
-
Manufacturing or process control
CGMP Deviations