D-1172-2023 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 27, 2023
- Initiation Date
- September 7, 2023
- Termination Date
- February 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69,707 cartons
Product Description
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96
Reason for Recall
Subpotent: Out of Specification result observed for low assay
Distribution Pattern
Nationwide wide in the USA
Code Information
Lot# 10026, Lot 10027, Exp. 09/2023.