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FDAFDA · Food and drugs·Recall number D-0386-2023

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

Published March 8, 2023 · Recall initiated: February 7, 2023

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

CGMP Deviations: recalling drug products following an FDA inspection.

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
DOXAZOSIN
Manufacturer
Accord Healthcare, Inc.
Distributor
United States including Puerto Rico and Canada
UPC
316729211017
Lot
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;
Risk classification
Class II
Area (FDA)
drug
Country
United States

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