FDA-Drug2022-04-13Class III
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
Hazard
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Sold states
Nationwide in the USA.
Affected count
73,030 boxes
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0770-2022More SUN PHARMACEUTICAL INDUSTRIES INC recalls
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- FDA-Drug2026-04-22Taro Fluocinonide 0.05% Cream recalled for failed viscosity specifications
- FDA-Drug2026-04-22Taro Pharmaceuticals fluocinonide cream recalled for failed viscosity specifications
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