April 2022 FDA Recall Cequa by Sun Pharmaceutical Industries Inc
D-0770-2022 - Subpotent Drug and Presence of Particulate Matter

This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on April 1, 2022 for the product Cequa. The FDA reported the reason for recall as subpotent drug and presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0770-2022

Reason for Recall
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Initiated
04-01-2022
Reported
04-13-2022
Quantity
73,030 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89917
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 in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-21-2023
Product Description About Product Description
Full technical description of the product.
Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96

Batch or Lot Expiration Information

Lot# Lot: 10014, 10016, Exp 08/2022

Affected Packages Involved in this Recall

47335-506-96 Cequa
47335-507-97 Cequa