Class III
Terminated
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
- Recall Initiated
- April 1, 2022
- Posted
- April 13, 2022
- Recall Number
- D-0770-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 73,030 boxes
- Firm Location
- Princeton, NJ, United States
Reason for Recall
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Distribution
Nationwide in the USA.
Lot / Code Info
Lot: 10014, 10016, Exp 08/2022
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