Compounded Eye Injection Recalled

Two lots of compounded epinephrine 0.025% and lidocaine HCl 0.75% intraocular solution for injection are being recalled by Imprimis NJOF. The May 8, 2024, US Food and Drug Administration (FDA) Enforcement Report states the solution is “out of specification for assay.”

The recall affects epinephrine-lidocaine HCl 0.25 mg/mL and 7.5 mg/mL, preservative-free, 1-mL single-use vials (NDC 71384-640-01), from lots 23JUL028 (Exp. 8/1/24) and 23AUG053 (Exp. 8/30/24). The vials were distributed throughout the United States. Imprimis NJOF voluntarily initiated the recall April 10, 2024. The FDA designated it a Class III on April 30, 2024. Per the designation, use of the affected drug is not likely to cause 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.