September 2023 FDA Recall Cequa by Sun Pharmaceutical Industries Inc
D-1172-2023 - Subpotent
This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on September 7, 2023 for the product Cequa. The FDA reported the reason for recall as subpotent. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1172-2023
Subpotent: Out of Specification result observed for low assay
09-07-2023
09-27-2023
69,707 cartons
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 wide in the USA
02-13-2024
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 NDC 47335-506-96
Batch or Lot Expiration Information
Lot# 10026, Lot 10027, Exp. 09/2023.
