Drug product
Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96
D-0770-2022
Product summary
- Event
- Event 89917
- Status
- Terminated
- Classification
- Class III
- Quantity
- 73,030 boxes
- Official record key
drug-enforcement:D-0770-2022
Official wording
Reason: Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Code information: Lot: 10014, 10016, Exp 08/2022
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter
-
Potency or specification failure
Subpotent