FDAClass IIISeptember 27, 2023

Cequa (cyclosporine ophthalmic solution) 0.09% recall: Subpotent

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…

Why was Cequa (cyclosporine ophthalmic solution) 0.09% recalled?

Subpotent: Out of Specification result observed for low assay

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 10026, Lot 10027, Exp. 09/2023.

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…
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Quantity
69,707 cartons
Distribution
Nationwide wide in the USA
Recall date
September 27, 2023
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls