Klarity-C Ophthalmic Emulsion Recalled Due to Sterility Assurance Risk
Imprimis is recalling Klarity-C, a cyclosporine eye medication, because the company cannot assure the product meets sterility standards. Approximately 136,005 units were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterile pharmaceutical product lacking verified sterility assurance. While no illnesses or injuries have been reported, the potential for microbial contamination in an ophthalmic medication poses a risk to patient safety.
Plain-English summary
Imprimis NJOF, LLC is recalling Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1%, a compounded eye medication supplied for office use. The recall affects 136,005 units with lot numbers and expiration dates ranging from May 2024 through December 2024.
The manufacturer is recalling the product due to lack of assurance of sterility—meaning it cannot verify that the product maintains the required sterility standards.
Medical offices that have received this product should discontinue use of remaining supplies and contact Imprimis for further instructions. Patients who have received this medication should consult with their healthcare provider about any concerns.
The recalled product
- Product
- Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852 NDC: 71384-514-05
- Manufacturer
- Imprimis NJOF, LLC
- Category
- Drug — Ophthalmic Medication
- Hazard
- sterility-risk
- contamination-risk
Distribution
Distributed nationwide across the United States.
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