Why it was recalled
Discoloration: Dotted and yellow spots on tablets
Product description
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Lot numbers, UPCs & expiration codes
Lot #s: a) CZB124001B, CZB124002B, CZB124003B, Exp. 12/31/2025; b) CZB124001A, CZB124003A, Exp. 12/31/2025.
Where it was sold
Nationwide in the USA
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-0492-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 24, 2024
- FDA report date
- May 15, 2024
- Quantity
- 6909 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-0492-2024, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94500
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #s: a) CZB124001B, CZB124002B, CZB124003B, Exp. 12/31/2025; b) CZB124001A, CZB124003A, Exp. 12/31/2025.
- Postal code
- 08520-1401
- Report date
- May 15, 2024
- Product type
- Drugs
- Recall number
- D-0492-2024
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 6909 bottles
- Reason for recall
- Discoloration: Dotted and yellow spots on tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 24, 2024
- Initial firm notification
- Letter
- Center classification date
- May 8, 2024