FDA 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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-04-24

Report date

2024-05-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0491-2024