Recalls / Class III
Class IIID-1445-2020
Product
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86
- Affected lot / code info
- Lot #: AA84106, Exp 9/2021
Why it was recalled
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 3516 bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2020-07-06
- FDA classified
- 2020-07-30
- Posted by FDA
- 2020-08-05
- Terminated
- 2023-06-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1445-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.