Status
Terminated
Drug Enforcement D-0387-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Classification
Class II
Report Date
March 8, 2023
Termination Date
April 22, 2024
Product Information
- Product description
- 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
- Product quantity
- 69,122 bottles
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- United States including Puerto Rico and Canada
Location & Firm
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Address
-
1009 Slater Rd Ste 210B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0387-2023
- Event ID
- 91657
- Recall initiation date
- February 7, 2023
- Center classification date
- March 2, 2023
- 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;
- More code info
- —