Class IIOngoing

Clorazepate Dipotassium Tablets recall

FDA recall D-0491-2024 · initiated Apr 24, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Discoloration: Dotted and yellow spots on tablets

Details

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.
Recalling company: Aurobindo Pharma Limited
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Apr 24, 2024
FDA report date: May 15, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0491-2024 ↗

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