Recalls / Class II
Class IID-0387-2023
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
- Brand name
- Doxazosin
- Generic name
- Doxazosin
- Active ingredient
- Doxazosin Mesylate
- Route
- Oral
- NDCs
- 16729-211, 16729-414, 16729-213, 16729-415
- FDA application
- ANDA202824
- Affected lot / code info
- 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;
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Manufacturer
- Accord Healthcare Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446
Distribution
- Quantity
- 69,122 bottles
- Distribution pattern
- United States including Puerto Rico and Canada
Timeline
- Recall initiated
- 2023-02-07
- FDA classified
- 2023-03-02
- Posted by FDA
- 2023-03-08
- Terminated
- 2024-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0387-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.