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Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals ...

FDA Recall #D-0463-2023 — Class II — March 2, 2023

Recall #D-0463-2023 Date: March 2, 2023 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

CGMP Deviations: Potential risk of Cross Contamination

Recalling Firm

Breckenridge Pharmaceutical, Inc — Berlin, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

N/A

Distribution

USA nationwide.

Code Information

Lot # 5210147, Exp 12/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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