Recalls / Class II

Class IID-0547-2024

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

Affected lot / code info

Lot:23APR005 Exp. 5/1/2024 Lot:23MAY024 Exp. 5/15/2024 Lot:23JUN010 Exp. 5/30/2024 Lot:23JUN016 Exp. 6/7/2024 Lot:23JUN047 Exp. 7/4/2024 Lot:23JUL013 Exp. 7/11/2024 Lot:23JUL029 Exp. 7/25/2024 Lot:23JUL030 Exp. 8/1/2024 Lot:23AUG016 Exp. 8/7/2024 Lot:23AUG042 Exp. 9/27/2024 Lot:23SEP017 Exp. 7/13/2024 Lot:23OCT039 Exp. 8/3/2024 Lot:23NOV022 Exp. 8/24/2024 Lot:23NOV036 Exp. 8/29/2024 Lot:23DEC021 Exp. 10/4/2024 Lot:24JAN018 Exp. 10/11/2024 Lot:24JAN026 Exp. 10/24/2024 Lot:24JAN040 Exp. 11/2/2024 Lot:24FEB021 Exp. 11/16/2024 Lot:24MAR005 Exp. 12/12/2024

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

Imprimis NJOF, LLC

Notification channel

N/A

Type

Voluntary: Firm initiated

Address

1705 Route 46 Ste 6B, N/A, Ledgewood, New Jersey 07852-9720

Distribution

Quantity

136,005 units

Distribution pattern

US Nationwide

Timeline

Recall initiated

2024-05-14

FDA classified

2024-06-07

Posted by FDA

2024-06-19

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0547-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.