Why it was recalled
CGMP Deviations: Potential risk of Cross Contamination
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
Lot numbers, UPCs & expiration codes
Lot # 5210085, Exp 12/2023; 5210248, Exp 01/2024; 5220796, Exp 07/2025
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0462-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 2, 2023
- FDA report date
- Mar 22, 2023
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc
Original FDA data
Every field from FDA enforcement report D-0462-2023, exactly as published.
Show all FDA fields
- City
- Berlin
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 91786
- Address
- 15 Massirio Dr Ste 201
- Code information
- Lot # 5210085, Exp 12/2023; 5210248, Exp 01/2024; 5220796, Exp 07/2025
- Postal code
- 06037-2352
- Report date
- Mar 22, 2023
- Product type
- Drugs
- Recall number
- D-0462-2023
- Classification
- Class II
- Recalling firm
- Breckenridge Pharmaceutical, Inc
- Termination date
- Mar 21, 2024
- Reason for recall
- CGMP Deviations: Potential risk of Cross Contamination
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Mar 2, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 10, 2023