May 2021 FDA Recall Cequa by Sun Pharmaceutical Industries Inc
D-0391-2021 - Subpotent and Presence of Particulates .
This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on May 7, 2021 for the product Cequa. The FDA reported the reason for recall as subpotent and presence of particulates .. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0391-2021
Subpotent and Presence of Particulates .
05-07-2021
05-26-2021
N/A
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
06-17-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96
Batch or Lot Expiration Information
Lot# 10009, exp. date 03/2022 10006, exp. date 01/2022
