Drug recall D-0386-2023
Product
Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7; b) 1,000-count bottle NDC 16729-211-17 UPC 3 16729 21117 8; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
Batches: a) R2200402, Exp. Date 5/31/2024; R2200642, Exp. Date 5/31/2024; R2200643 Exp. Date 8/31/2024; R2201300 Exp. Date 8/31/2024; b) R2200403, Exp. Date 5/31/2024;
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 44,068 bottles
- Distribution
- United States including Puerto Rico and Canada
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 7, 2023
- Terminated
- April 22, 2024
Related products
- Doxazosin – drug information
- NDC 16729-211 Doxazosin · Doxazosin Mesylate 1 mg/1 · Accord Healthcare Inc.
- NDC 16729-213 Doxazosin · Doxazosin Mesylate 4 mg/1 · Accord Healthcare Inc.
- NDC 16729-414 Doxazosin · Doxazosin Mesylate 2 mg/1 · Accord Healthcare Inc.
- NDC 16729-415 Doxazosin · Doxazosin Mesylate 8 mg/1 · Accord Healthcare Inc.