Drug Enforcement D-0386-2023

CGMP Deviations: recalling drug products following an FDA inspection.

Status

Terminated

Classification

Class II

Report Date

March 8, 2023

Termination Date

April 22, 2024

Product Information

Product description
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
Product quantity
44,068 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-0386-2023
Event ID
91657
Recall initiation date
February 7, 2023
Center classification date
March 2, 2023
Code info
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;
More code info
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