Clobazam tablets recalled for potential manufacturing cross-contamination risk
Breckenridge Pharmaceuticals is recalling certain lots of Clobazam 10 mg tablets due to a potential cross-contamination risk stemming from manufacturing process deviations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with theoretical hazard (potential contamination) and no reported illnesses or injuries. This is a precautionary, manufacturing-practice-based recall fitting the criterion for low-risk contamination.
Plain-English summary
Breckenridge Pharmaceuticals, Inc. is recalling specific lots of Clobazam Tablets 10 mg manufactured by Centaur Pharmaceuticals Pvt. Ltd. (Pune, India) and distributed throughout the United States.
The recall was issued because the manufacturing facilities deviated from Current Good Manufacturing Practice (CGMP) standards, creating a potential risk of cross-contamination during production.
The affected lots are: Lot #5210085 (expires 12/2023), Lot #5210248 (expires 01/2024), and Lot #5220796 (expires 07/2025). Patients taking Clobazam should not stop their medication without consulting their healthcare provider. Contact your pharmacy or healthcare provider for guidance; they can verify if your medication is from a recalled lot.
The recalled product
- 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
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Category
- Drug
- Hazard
- cross-contamination
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot # 5210085
- Exp 12/2023
- 5210248
- Exp 01/2024
- 5220796
- Exp 07/2025
Distribution
Distributed nationwide across the United States.
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