Recall: D-0491-2024

Class II - Potentially Harmful

Class IIClassification

2024-04-24Initiated

OngoingStatus

Aurobindo Pharma USA Inc.Firm

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

Discoloration: Dotted and yellow spots on tablets

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.