Reported Mar 10, 2021 · Terminated
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)),…
Sun Pharmaceutical Industries Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- 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 byLaboratoire Unither, Coutances, France NDC 47335-506-96
- Lot codes and dates
Lot 10007exp. date 01/2022
- Amount recalled
- 37,400 cartons/60 vials per carton
Where it was sold
- Nationwide
Why it was recalled
Subpotent
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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