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-0289-2021
Product summary
- Event
- Event 87349
- Status
- Terminated
- Classification
- Class III
- Quantity
- 37,400 cartons/60 vials per carton
- Official record key
drug-enforcement:D-0289-2021
Official wording
Reason: Subpotent
Code information: Lot 10007, exp. date 01/2022
Distribution pattern: Nationwide and Australia
Derived failure modes
-
Potency or specification failure
Subpotent