Drug product
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.
D-0491-2024
Product summary
- Event
- Event 94500
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6696 bottles
- Official record key
drug-enforcement:D-0491-2024
Official wording
Reason: Discoloration: Dotted and yellow spots on tablets
Code information: Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Discoloration: Dotted and yellow spots on tablets