FDA-Drug2024-05-15Class II

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.

Aurobindo Pharma USA Inc.
Hazard

Discoloration: Dotted and yellow spots on tablets

Sold states
Nationwide in the USA
Affected count
6696 bottles
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
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.

Official notice

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

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