D-0770-2022 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 13, 2022
- Initiation Date
- April 1, 2022
- Termination Date
- July 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73,030 boxes
Product Description
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot: 10014, 10016, Exp 08/2022