Clobazam Tablets Recalled Due to Cross Contamination Risk
Breckenridge Pharmaceutical is recalling Clobazam 20 mg tablets (Lot #5210147, exp. 12/2023) nationwide due to potential cross contamination from manufacturing deviations.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with potential cross contamination due to CGMP deviations. No illnesses or injuries have been reported, which caps the severity at High per the rubric for theoretical hazards without reported harm.
Plain-English summary
Clobazam Tablets, 20 mg (Lot #5210147, expiration 12/2023) manufactured by Centaur Pharmaceuticals Pvt. Ltd. and distributed by Breckenridge Pharmaceutical, Inc. are being recalled.
The FDA-classified Class II recall was issued due to potential cross contamination resulting from Current Good Manufacturing Practice (CGMP) deviations. No illnesses or injuries have been reported related to this product.
The affected medication was distributed nationwide. Patients currently taking this product should consult their healthcare provider or pharmacist before discontinuing use.
The recalled product
- 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
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Category
- Drug
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 (2)
- Lot # 5210147
- Exp 12/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Breckenridge Pharmaceutical, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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