D-0491-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- May 15, 2024
- Initiation Date
- April 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6696 bottles
Product Description
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Reason for Recall
Discoloration: Dotted and yellow spots on tablets
Distribution Pattern
Nationwide in the USA
Code Information
Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025.