D-0391-2021 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 26, 2021
- Initiation Date
- May 7, 2021
- Termination Date
- June 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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 Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96
Reason for Recall
Subpotent and Presence of Particulates .
Distribution Pattern
Nationwide in the US
Code Information
Lot # 10009, exp. date 03/2022 10006, exp. date 01/2022