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
Reported: September 27, 2023 Initiated: September 7, 2023 #D-1172-2023
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
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 69,707 cartons
- Distribution
- Nationwide wide in the USA
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 69,707 cartons.
Why was this product recalled? ▼
Subpotent: Out of Specification result observed for low assay
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 27, 2023. Severity: Low. Recall number: D-1172-2023.
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