FDAFDA · Food and drugs·Recall number D-0770-2022
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
Published April 13, 2022 · Recall initiated: April 1, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CEQUA
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide in the USA.
- Lot
- Lot: 10014, 10016, Exp 08/2022
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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