Drug product
rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-234-01, UPC 3 16729 23401 6
D-0427-2023
Product summary
- Event
- Event 91657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 104,945 bottles
- Official record key
drug-enforcement:D-0427-2023
Official wording
Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Code information: Batches: P2103544 Exp. Date 5/31/2023, P2106132, P2106131, P2106128, P2106129, P2106130, P2106133, Exp. Date 8/31/2023, P2107662, P2107663, P2107664, Exp. Date 11/30/2023, P2203543, Exp. Date 5/31/2024
Distribution pattern: United States including Puerto Rico and Canada
Derived failure modes
-
Manufacturing or process control
CGMP Deviations