D-1445-2020 Class III Terminated
FDA drug recall D-1445-2020 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on July 6, 2020 and is designated Class III. Reason for recall: Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine The recall status is terminated (terminated June 8, 2023). Affected quantity: 3516 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 5, 2020
- Initiation Date
- July 6, 2020
- Termination Date
- June 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3516 bottles
Product Description
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
Reason for Recall
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Distribution Pattern
Nationwide USA
Code Information
Lot #: AA84106, Exp 9/2021