Multi-event March 2023 FDA Recall Drug by Breckenridge Pharmaceutical, Inc
This Multi-event Class II drug recall was voluntarily initiated by Breckenridge Pharmaceutical, Inc on March 2, 2023 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0460-2023
CGMP Deviations: Potential risk of Cross Contamination
03-02-2023
03-22-2023
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
03-21-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.
Batch or Lot Expiration Information
Lot# 5210645, exp. date 3/31/2023, 500's Bottle 5210646, exp. date 3/31/2023, 500's Bottle 5210647, exp. date 3/31/2023, 500's Bottle 5210648, exp. date 3/31/2023, 1000's Bottle 5210649, exp. date 3/31/2023, 1000's Bottle 5210831, exp. date 4/30/2023, 100's Bottle 5210832, exp. date 4/30/2023, 500's Bottle 5210833, exp. date 4/30/2023, 500's Bottle 5210834, exp. date 4/30/2023, 1000's Bottle 5210835, exp. date 4/30/2023, 1000's Bottle 5210905, exp. date 5/31/2023, 100's Bottle 5210906, exp. date 5/31/2023, 100's Bottle 5210907, exp. date 5/31/2023, 500's Bottle 5210908, exp. date 5/31/2023, 500's Bottle 5210909, exp. date 5/31/2023, 500's Bottle 5210965, exp. date 5/31/2023, 500's Bottle 5210997, exp. date 5/31/2023, 1000's Bottle 5210998, exp. date 5/31/2023, 1000's Bottle 5211175, exp. date 6/30/2023, 1000's Bottle 5211176, exp. date 6/30/2023, 500's Bottle 5211177, exp. date 6/30/2023, 500's Bottle 5211178, exp. date 6/30/2023, 500's Bottle 5211179, exp. date 6/30/2023, 500's Bottle 5211180, exp. date 6/30/2023, 500's Bottle 5211181, exp. date 6/30/2023, 500's Bottle 5211205, exp. date 7/31/2023, 500 s Bottle 5211206, exp. date 7/31/2023, 500's Bottle 5211227, exp. date 7/31/2023, 1000's Bottle 5211228, exp. date 7/31/2023, 100's Bottle 5211229, exp. date 7/31/2023, 1000's Bottle 5211334, exp. date 8/31/2024, 500's Bottle 5211335, exp. date 8/31/2024, 1000's Bottle 5211456, exp. date 8/31/2024 , 500's Bottle 5211457, exp. date 8/31/2024 , 500's Bottle 5211458, exp. date 8/31/2024, 500's Bottle 5211459, exp. date 9/30/2024, 1000's Bottle 5211727, exp. date 11/30/2024, 100's Bottle 5211730, exp. date 11/30/2024, 1000's Bottle 5220028, exp. date 12/31/2024, 1000's Bottle 5220029, exp. date 12/31/2024, 1000's Bottle 5220288, exp. date 2/28/2025, 100's Bottle
Recall Number: D-0458-2023
CGMP Deviations: Potential risk of Cross Contamination
03-02-2023
03-22-2023
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
03-21-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.
Batch or Lot Expiration Information
Lot# a) 5210734, Exp 4/30/2023; 5211451, Exp 8/31/2024; 5220529, Exp 4/30/2025; b) 5210735, Exp 4/30/2023; 5210736, Exp 4/30/2023, 5210993, Exp 5/31/20; 5210994, Exp 5/31/2023, 5211100, Exp 6/30/2023, 5211452, Exp 8/31/2024, 5211453, Exp 8/31/2024, 5211454, Exp 8/31/2024, 5211640, Exp 10/31/2024, 5211641, Exp 10/31/2024; c) 5210737, Exp 4/30/2023; 5210995, Exp 5/31/2023; 5211101, Exp 6/30/2023, 5211269, Exp 7/31/2024, 5211270, Exp 7/31/2024, 5211271, Exp 7/31/2024.
Recall Number: D-0459-2023
CGMP Deviations: Potential risk of Cross Contamination
03-02-2023
03-22-2023
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
03-21-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.
Batch or Lot Expiration Information
Lot# a) 5210673, exp. date 3/31/2023; 5210901, exp. date 5/31/2023; 5211461, exp. date 9/30/2024; 5220291, exp. date 2/28/2025; 5220559, exp. date 5/31/2025; b) 5210650, exp. date 3/31/2023, 5210651, exp. date 3/31/2023 5210652, exp. date 3/31/2023 5210653, exp. date 3/31/2023 5210674, exp. date 3/31/2023 5210732, exp. date 3/31/2023 5210733, exp. date 4/30/2023 5210753, exp. date 4/30/2023 5210902, exp. date 5/31/2023 5210903, exp. date 5/31/2023 5210904, exp. date 5/31/2023 5211231, exp. date 7/31/2023 5211281, exp. date 7/31/2024 5211282, exp. date 7/31/2024 5211283, exp. date 7/31/2024 5211284, exp. date 7/31/2024 5211336, exp. date 7/31/2024 5211337, exp. date 8/31/2024 5211338, exp. date 8/31/2024 5211462, exp. date 9/30/2024 5211463, exp. date 9/30/2024 5211464, exp. date 9/30/2024 5211465, exp. date 9/30/2024 5211516, exp. date 9/30/2024 5211644, exp. date 10/31/2024 5211645, exp. date 10/31/2024 5211690, exp. date 10/31/2024 c) 5210675, exp. date 3/31/2023 5210777, exp. date 4/30/2023 5210778, exp. date 4/30/2023 5210996, exp. date 5/31/2023 5211077, exp. date 6/30/2023 5211078, exp. date 6/30/2023 5211079, exp. date 6/30/2023 5211080, exp. date 6/30/2023 5211364, exp. date 8/31/2024 5211365, exp. date 8/31/2024 5211367, exp. date 8/31/2024 5211366, exp. date 8/31/2024 5211575, exp. date 10/31/2024 5211576, exp. date 10/31/2024 5211694, exp. date 11/30/2024 5220066, exp. date 12/31/2024
Recall Number: D-0461-2023
CGMP Deviations: Potential risk of Cross Contamination
03-02-2023
03-22-2023
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
03-21-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.
Batch or Lot Expiration Information
Lot# 5210546, exp. date 3/31/2023, 100's Bottle 5210547, exp. date 3/31/2023, 500's Bottle 5210548, exp. date 3/31/2023, 500's Bottle 5210642, exp. date 3/31/2023, 100's Bottle 5210643, exp. date 3/31/2023, 100's Bottle 5210644, exp. date 3/31/2023, 500's Bottle 5210766, exp. date 4/30/2023, 100's Bottle 5210767, exp. date 4/30/2023, 100's Bottle 5210768, exp. date 4/30/2023, 500's Bottle 5210999, exp. date 5/31/2023, 500's Bottle 5211000, exp. date 5/31/2023, 500's Bottle 5211001, exp. date 5/31/2023, 500's Bottle 5211002, exp. date 5/31/2023, 500's Bottle 5211003, exp. date 5/31/2023, 500's Bottle 5211004, exp. date 6/30/2023, 500's Bottle 5211005, exp. date 6/30/2023, 500's Bottle 5211006, exp. date 6/30/2023, 500's Bottle 5211055, exp. date 6/30/2023, 500's Bottle 5211332, exp. date 7/31/2024, 500's Bottle 5211333, exp. date 7/31/2024, 500's Bottle 5211339, exp. date 7/31/2024, 100's Bottle 5211340, exp. date 7/31/2024, 100's Bottle 5211341, exp. date 7/31/2024, 100's Bottle 5211363, exp. date 8/31/2024, 100's Bottle 5220313, exp. date 2/28/2025, 500's Bottle 5220314, exp. date 2/28/2025, 500's Bottle 5220315, exp. date 2/28/2025, 500's Bottle
Recall Number: D-0463-2023
CGMP Deviations: Potential risk of Cross Contamination
03-02-2023
03-22-2023
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
03-21-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-901-01
Batch or Lot Expiration Information
Lot# 5210147, Exp 12/2023
Recall Number: D-0462-2023
CGMP Deviations: Potential risk of Cross Contamination
03-02-2023
03-22-2023
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
03-21-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-900-01
Batch or Lot Expiration Information
Lot# 5210085, Exp 12/2023; 5210248, Exp 01/2024; 5220796, Exp 07/2025
