Recalls / Class II
Class IID-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.
- Brand name
- Clorazepate Dipotassium
- Generic name
- Clorazepate Dipotassium
- Active ingredient
- Clorazepate Dipotassium
- Route
- Oral
- NDCs
- 13107-282, 13107-283, 13107-284
- FDA application
- ANDA071858
- Affected lot / code info
- Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025.
Why it was recalled
Discoloration: Dotted and yellow spots on tablets
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurolife Pharma LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 6696 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-04-24
- FDA classified
- 2024-05-08
- Posted by FDA
- 2024-05-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0491-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.