Subpotent Eye Solution Recalled

Sun Pharmaceutical Industries Inc is recalling two lots of Cequa (cyclosporine ophthalmic solution) 0.09% for subpotency, according to the September 20, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects Cequa, 60 single-use vials (0.25 mL each), 10 vials per pouch, 6 pouches per box (NDC 47335-506-96), from lots 10026 and 10027 (Exp. 9/23). The product was manufactured by Laboratoire Unither, Coutances, France, for Sun Pharma Global FZE and distributed throughout the US.

Sun Pharmaceutical Industries voluntarily initiated the recall September 7, 2023. On September 20, 2023, the FDA designated the recall Class III. Per the recall classification, use of the affected solution is not likely to cause harm.

Cequa is a prescription ophthalmic solution indicated to increase tear production in patients with dry eye.