Drug recall D-0491-2024
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.
Reason for recall
Discoloration: Dotted and yellow spots on tablets
Lots and codes
Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025.
Recall details
- Recalling firm
- Aurobindo Pharma USA Inc., East Windsor, NJ
- Quantity
- 6696 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 24, 2024
Related products
- Clorazepate Dipotassium – drug information
- NDC 13107-282 Clorazepate Dipotassium · Clorazepate Dipotassium 3.75 mg/1 · Aurolife Pharma LLC
- NDC 13107-283 Clorazepate Dipotassium · Clorazepate Dipotassium 7.5 mg/1 · Aurolife Pharma LLC
- NDC 13107-284 Clorazepate Dipotassium · Clorazepate Dipotassium 15 mg/1 · Aurolife Pharma LLC