Drug recall D-0389-2023
Product
Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets NDC 16729-415-17 UPC 3 16729 41517 0; 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) R2200672, Exp. Date 5/31/2024; R2200673, Exp. Date 9/30/2024; R2201097, Exp. Date 7/31/2025; b) R2200678, Exp. Date 10/31/2024;
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 31,116 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.