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Recall Observatory FDA recall evidence

Drug product

Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1; b) 1,000-count bottle NDC 16729-213-17 UPC 3 16729 21317 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

D-0388-2023

February 07, 2023

Class II

Product summary

Firm
Accord Healthcare, Inc.
Event
Event 91657
Status
Terminated
Classification
Class II
Quantity
75,190 bottles
Official record key
drug-enforcement:D-0388-2023

Official wording

Reason: CGMP Deviations: recalling drug products following an FDA inspection.

Code information: Batches: a) R2200352, Exp. Date 5/31/2024; R2200356, Exp. Date 8/31/2024; R2200357, Exp. Date 8/31/2024; R2200633, Exp. Date 4/30/2025; R2200634, Exp. Date 4/30/2025; b) R2200677,Exp. Date 8/31/2024; R2200572,Exp. Date 4/30/2025; R2200571, Exp. Date 4/30/2025; R2200646, Exp. Date 4/30/2025;

Distribution pattern: United States including Puerto Rico and Canada

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations