Ophthalmic Emulsion Recalled
Imprimis NJOF is recalling 136,005 units of Klarity-C Drops (cyclosporine 0.1%) preservative-free ophthalmic emulsion for topical use because of sterility concerns, according to the June 19, 2024, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects Klarity-C Drops in 5.5-mL bottles (NDC 71384-514-05) from lots 23APR005 (Exp. 5/1/24), 23MAY024 (Exp. 5/15/24), 23JUN010 (Exp. 5/30/24), 23JUN016 (Exp. 6/7/24), 23JUN047 (Exp. 7/4/24), 23JUL013 (Exp. 7/11/24), 23JUL029 (Exp. 7/25/24), 23JUL030 (Exp. 8/1/24), 23AUG016 (Exp. 8/7/24), 23AUG042 (Exp. 9/27/24), 23SEP017 (Exp. 7/13/24), 23OCT039 (Exp. 8/3/24), 23NOV022 (Exp. 8/24/24), 23NOV036 (Exp. 8/29/24), 23DEC021 (Exp. 10/4/24), 24JAN018 (Exp. 10/11/24), 24JAN026 (Exp. 10/24/24), 24JAN040 (Exp. 11/2/24), 24FEB021 (Exp. 11/16/24), and 24MAR005 (Exp. 12/12/24).
The drug was compounded by Imprimis NJOF, Ledgewood, New Jersey, and was distributed throughout the United States.
Imprimis NJOF voluntarily initiated the recall on May 14, 2024. The FDA designated the recall Class II on June 7, 2024. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used, or a remote possibility of serious harm.
The prescription emulsion is an immune modulator. Possible indications include keratoconjunctivitis sicca, according to the ImprimisRx website.
