Buspirone Hydrochloride Tablet
FDA Recall NDC 16729-201
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Buspirone Hydrochloride (NDC 16729-201). 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
23,784 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
BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-201-01
Batch or Lot Expiration Information
Batch# Batches: P2105532, Exp. Date 6/30/2024; P2200348, Exp. Date 12/31/2024
Affected Packages Involved in this Recall
16729-203-12Product
16729-203-01Product
16729-203-59Product
16729-203-16Product
16729-203-17Product
16729-289-12Product
16729-289-01Product
16729-289-59Product
16729-289-16Product
16729-289-17Product
16729-200-01Product
16729-200-16Product
16729-200-17Product
16729-201-01Product
16729-201-16Product
16729-201-17Product
16729-202-01Product
16729-202-16Product
16729-202-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
3,784 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
BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-202-16 UPC 3 16729 20216 9
Batch or Lot Expiration Information
Batch# Batches: P2105472, Exp. Date 4/30/2024
Affected Packages Involved in this Recall
16729-203-12Product
16729-203-01Product
16729-203-59Product
16729-203-16Product
16729-203-17Product
16729-289-12Product
16729-289-01Product
16729-289-59Product
16729-289-16Product
16729-289-17Product
16729-200-01Product
16729-200-16Product
16729-200-17Product
16729-201-01Product
16729-201-16Product
16729-201-17Product
16729-202-01Product
16729-202-16Product
16729-202-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
10992 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
BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-203-01, UPC 3 16729 20301 2;
Batch or Lot Expiration Information
Batch# Batches: P2105483, Exp. Date 7/31/2024
Affected Packages Involved in this Recall
16729-203-12Product
16729-203-01Product
16729-203-59Product
16729-203-16Product
16729-203-17Product
16729-289-12Product
16729-289-01Product
16729-289-59Product
16729-289-16Product
16729-289-17Product
16729-200-01Product
16729-200-16Product
16729-200-17Product
16729-201-01Product
16729-201-16Product
16729-201-17Product
16729-202-01Product
16729-202-16Product
16729-202-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
24,408 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
BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) 500 Tablets NDC 16729-200-16 UPC 3 16729 20016 5; 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) P2200530, Exp. Date 12/31/2024; b) P2105583, Exp. Date 6/30/2024
Affected Packages Involved in this Recall
16729-203-12Product
16729-203-01Product
16729-203-59Product
16729-203-16Product
16729-203-17Product
16729-289-12Product
16729-289-01Product
16729-289-59Product
16729-289-16Product
16729-289-17Product
16729-200-01Product
16729-200-16Product
16729-200-17Product
16729-201-01Product
16729-201-16Product
16729-201-17Product
16729-202-01Product
16729-202-16Product
16729-202-17Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
25,812 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
BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-289-12 UPC 3 16729 28912 2
Batch or Lot Expiration Information
Batch# Batches: P2105551, Exp. Date 7/31/2024
Affected Packages Involved in this Recall
16729-203-12Product
16729-203-01Product
16729-203-59Product
16729-203-16Product
16729-203-17Product
16729-289-12Product
16729-289-01Product
16729-289-59Product
16729-289-16Product
16729-289-17Product
16729-200-01Product
16729-200-16Product
16729-200-17Product
16729-201-01Product
16729-201-16Product
16729-201-17Product
16729-202-01Product
16729-202-16Product
16729-202-17Product
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.
