Intraocular Injection Recalled

Imprimis NJOF is recalling 14,180 vials of epinephrine-lidocaine for intraocular injection due to a lack of assurance of sterility, according to the June 5, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects epinephrine-lidocaine HCl 0.25 mg/mL and 7.5 mg/mL, preservative-free, 1-mL single-use vials for intraocular injection (NDC 71384-640-01), from lots 23APR033 (Exp. 5/1/24) and 23JUN001 (Exp. 6/5/24). The injections were distributed throughout the United States.

Imprimis NJOF voluntarily initiated the recall on May 14, 2024. On May 29, 2024, the FDA designated the recall Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Epinephrine 0.025% and lidocaine HCl 0.75% is a mydriatic injection. Possible indications include intraoperative mydriasis, open-angle glaucoma, hemorrhage during ocular surgery, and ocular anesthesia, according to the ImprimisRx website.