FDAFDA · Food and drugs·Recall number D-0491-2024
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.
Published May 15, 2024 · Recall initiated: April 24, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Discoloration: Dotted and yellow spots on tablets
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CLORAZEPATE DIPOTASSIUM
- Manufacturer
- Aurobindo Pharma USA Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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