Drug 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
D-1445-2020
Product summary
- Event
- Event 85995
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3516 bottles
- Official record key
drug-enforcement:D-1445-2020
Official wording
Reason: Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Code information: Lot #: AA84106, Exp 9/2021
Distribution pattern: Nationwide USA
Derived failure modes
-
Unknown
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine