RecallDepth
Class III Terminated

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

Company
Sun Pharmaceutical Industries Inc
Recall Initiated
July 6, 2020
Posted
August 5, 2020
Recall Number
D-1445-2020
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
3516 bottles
Firm Location
Princeton, NJ, United States

Reason for Recall

Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

Distribution

Nationwide USA

Lot / Code Info

Lot #: AA84106, Exp 9/2021

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