Recalls / Class II
Class IID-1155-2022
Product
Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.
- Affected lot / code info
- Lot #: MHC1430A, Exp. Date 09/2023
Why it was recalled
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 4608 bottles
- Distribution pattern
- nationwide within the United States
Timeline
- Recall initiated
- 2022-06-03
- FDA classified
- 2022-06-22
- Posted by FDA
- 2022-06-29
- Terminated
- 2023-08-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1155-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.