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 Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96
D-0391-2021
Product summary
- Event
- Event 87922
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0391-2021
Official wording
Reason: Subpotent and Presence of Particulates .
Code information: Lot # 10009, exp. date 03/2022 10006, exp. date 01/2022
Distribution pattern: Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
Particulates
-
Potency or specification failure
Subpotent