Sun Pharma recalls Cequa (cyclosporine ophthalmic solution) 0.09% due to subpotent drug levels and particulate matter. Affected units have NDC 47335-506-96, lots 10014/10016, expiring 08/2022. Consumers should contact Sun Pharma for details.
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Sun Pharma is recalling Cequa (cyclosporine ophthalmic solution) 0.09% because lab tests found the drug strength was too low and there were particles in the solution. This could lead to ineffective treatment or eye irritation for people using the medication.
The medication contains less active drug than intended, which might not work well for treating eye inflammation. Particulate matter could cause eye irritation or block the medication's effectiveness.
People using Cequa for eye conditions, especially those with autoimmune diseases requiring immunosuppressants. Those with sensitive eyes may experience irritation or ineffective treatment.
Check for the product name 'Cequa' (0.09% cyclosporine ophthalmic solution) in 6 pouches with 10 single-use vials per box. The NDC code is 47335-506-96, and affected lots are 10014 or 10016, expiring in August 2022.
Look for the NDC code 47335-506-96 on the box, and check the lot number (10014 or 10016) and expiration date (08/2022).
The recall is due to subpotent drug levels and particulate matter, which could lead to ineffective treatment or eye irritation. Do not use the product until you contact Sun Pharma for instructions.
Check for the NDC code 47335-506-96, lot numbers 10014 or 10016, and expiration date of 08/2022 on the box.
Contact Sun Pharma directly for instructions on what to do with the product. The recall does not specify a return or disposal method.
We’ve drafted a message you can send Sun Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0770-2022 — Sun Pharma Sun Pharma Hello, I own a Sun Pharma that is covered by recall D-0770-2022 from Sun Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
