Drug product
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.
D-0492-2024
Product summary
- Event
- Event 94500
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6909 bottles
- Official record key
drug-enforcement:D-0492-2024
Official wording
Reason: Discoloration: Dotted and yellow spots on tablets
Code information: Lot #s: a) CZB124001B, CZB124002B, CZB124003B, Exp. 12/31/2025; b) CZB124001A, CZB124003A, Exp. 12/31/2025.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Discoloration: Dotted and yellow spots on tablets