Recalling firm
Aurobindo Pharma USA Inc.
Product type
Drug
Status
Ongoing
Report date
2024-05-15
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
6696 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Discoloration: Dotted and yellow spots on tablets
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.
Code / lot info
Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025.
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.