PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: June 19, 2024 Initiated: May 14, 2024 #D-0547-2024

Product Description

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

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Imprimis NJOF, LLC
Units Affected
136,005 units
Distribution
US Nationwide
Location
Ledgewood, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Imprimis NJOF, LLC. Units affected: 136,005 units.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on June 19, 2024. Severity: Moderate. Recall number: D-0547-2024.