June 2022 FDA Recall Drug by Sun Pharmaceutical Industries Inc
D-1155-2022 - Failed Tablet/Capsule Specification; oversized tablet found in a bottle

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on June 3, 2022 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specification; oversized tablet found in a bottle. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1155-2022

Reason for Recall
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Initiated
06-03-2022
Reported
06-29-2022
Quantity
4608 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90340
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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 within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-18-2023
Product Description About Product Description
Full technical description of the product.
Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.

Batch or Lot Expiration Information

Lot# : MHC1430A, Exp. Date 09/2023