Eye Injection Recalled

Pine Pharmaceuticals is recalling 11,453 single-dose vials of Epi-Caine (epinephrine 0.025%, lidocaine HCL 0.75%) solution for intraocular injection, according to the January 11, 2023, US Food and Drug Administration (FDA) Enforcement Report. The recall was prompted by a raw material recall by the repackager due to discoloration.

The recall affects Epi-Caine (epinephrine 0.025%, lidocaine HCL 0.75%) solution for intraocular injection, 1 mL (NDC 69194-0948-1), compounded by Pine Pharmaceuticals, Tonawanda, New York, from lots 62881 (Exp. 12/25/22), 62923 (Exp. 12/26/22), 63066 (Exp. 1/3/23), 63067 (Exp. 1/1/23), 63103 (Exp. 1/2/23), 63120 (Exp. 1/3/23), 63219 and 63226 (Exp. 1/8/23), 63263 (Exp. 1/9/23), 63380 and 63381 (Exp. 1/15/23), 63433 (Exp. 1/16/23), 63455 (Exp. 1/17/23), 63537 (Exp. 1/22/23), 63580 (Exp. 1/23/23), 63721 (Exp. 1/29/23), 63792 (Exp. 1/31/23), 63888 (Exp. 2/5/23), 63930 (Exp. 2/6/23), 63959 (Exp. 2/7/23), 64079 (Exp. 2/13/23), 64109 (Exp. 2/14/23), and 64239 (Exp. 2/21/23). The vials were distributed to medical facilities throughout the United States.

Pine Pharmaceuticals voluntarily initiated the recall December 22, 2022. At the time of the enforcement report, the FDA had not yet issued a recall classification.

Epinephrine and lidocaine hydrochloride is used as an intracameral mydriatic.