Drug 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
D-1172-2023
Product summary
- Event
- Event 93006
- Status
- Terminated
- Classification
- Class III
- Quantity
- 69,707 cartons
- Official record key
drug-enforcement:D-1172-2023
Official wording
Reason: Subpotent: Out of Specification result observed for low assay
Code information: Lot# 10026, Lot 10027, Exp. 09/2023.
Distribution pattern: Nationwide wide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent