Doxazosin Tablet
FDA Recall NDC 16729-415
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Doxazosin (NDC 16729-415). A significant event, classified as Class II, was initiated on Feb 07, 2023 by Accord Healthcare Inc.. The reported reason for this action was: "CGMP Deviations: recalling drug products following an FDA inspection."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
44,068 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
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
Batch or Lot Expiration Information
Batch# 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
Affected Packages Involved in this Recall
16729-414-01Product
16729-414-17Product
16729-211-01Product
16729-211-17Product
16729-213-01Product
16729-213-17Product
16729-415-01Product
16729-415-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
69,122 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
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
Batch or Lot Expiration Information
Batch# 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
Affected Packages Involved in this Recall
16729-414-01Product
16729-414-17Product
16729-211-01Product
16729-211-17Product
16729-213-01Product
16729-213-17Product
16729-415-01Product
16729-415-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
31,116 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets NDC 16729-415-17 UPC 3 16729 41517 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Batch or Lot Expiration Information
Batch# Batches: a) R2200672, Exp. Date 5/31/2024; R2200673, Exp. Date 9/30/2024; R2201097, Exp. Date 7/31/2025; b) R2200678, Exp. Date 10/31/2024
Affected Packages Involved in this Recall
16729-414-01Product
16729-414-17Product
16729-211-01Product
16729-211-17Product
16729-213-01Product
16729-213-17Product
16729-415-01Product
16729-415-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
75,190 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
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
Batch or Lot Expiration Information
Batch# 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
Affected Packages Involved in this Recall
16729-414-01Product
16729-414-17Product
16729-211-01Product
16729-211-17Product
16729-213-01Product
16729-213-17Product
16729-415-01Product
16729-415-17Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
