D-0289-2021 Class III Terminated
FDA drug recall D-0289-2021 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on February 22, 2021 and is designated Class III. Reason for recall: Subpotent The recall status is terminated (terminated January 21, 2022). Affected quantity: 37,400 cartons/60 vials per carton.
Recall Details
- Product Type
- Drugs
- Report Date
- March 10, 2021
- Initiation Date
- February 22, 2021
- Termination Date
- January 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37,400 cartons/60 vials per carton
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
Distribution Pattern
Nationwide and Australia
Code Information
Lot 10007, exp. date 01/2022