Drug product
Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2; b) 1,000-count NDC 16729-414-17 UPC 3 16729 41417 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
D-0387-2023
Product summary
- Event
- Event 91657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 69,122 bottles
- Official record key
drug-enforcement:D-0387-2023
Official wording
Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Code information: Batches: a) R2200401, Exp. Date 5/31/2024; R2200675, Exp. Date 5/31/2024; R2200676 Exp. Date 11/30/2024; R2201070, Exp. Date 7/31/2025; b) R2200680, Exp. Date 9/30/2024;
Distribution pattern: United States including Puerto Rico and Canada
Derived failure modes
-
Manufacturing or process control
CGMP Deviations