Drug recall D-0388-2023

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

Reason for recall

CGMP Deviations: recalling drug products following an FDA inspection.

Lots and codes

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;