Drug Enforcement D-0462-2023

CGMP Deviations: Potential risk of Cross Contamination

Status

Terminated

Classification

Class II

Report Date

March 22, 2023

Termination Date

March 21, 2024

Product Information

Product description
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
Product quantity
N/A
Reason for recall
CGMP Deviations: Potential risk of Cross Contamination
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA nationwide.

Location & Firm

Recalling firm
Breckenridge Pharmaceutical, Inc
Address
15 Massirio Dr Ste 201, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0462-2023
Event ID
91786
Recall initiation date
March 2, 2023
Center classification date
March 10, 2023
Code info
Lot # 5210085, Exp 12/2023; 5210248, Exp 01/2024; 5220796, Exp 07/2025
More code info
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