July 2020 FDA Recall Drug by Sun Pharmaceutical Industries Inc
D-1445-2020 - Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on July 6, 2020 for the product Drug. The FDA reported the reason for recall as cross contamination with other products - oos discovered during routine stability testing for highest unknown impurity later identified as clozapine. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1445-2020

Reason for Recall
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Initiated
07-06-2020
Reported
08-05-2020
Quantity
3516 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85995
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : AA84106, Exp 9/2021