Drug recall D-0770-2022
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
Reason for recall
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Lots and codes
Lot: 10014, 10016, Exp 08/2022
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 73,030 boxes
- Distribution
- Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 1, 2022
- Terminated
- July 21, 2023
Related products
- Cequa – drug information
- NDC 47335-507 Cequa · Cyclosporine .0009 mg/mL · Sun Pharmaceutical Industries, Inc.
- NDC 47335-506 Cequa · Cyclosporine .0009 g/mL · Sun Pharmaceutical Industries, Inc.