Epi-Caine recalled over manufacturing violations

Recall date

December 22, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pine Pharmaceuticals, LLC recalls Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounde…

Recall number

D-0130-2023

FDA classification

Class II

Brand / firm

Pine Pharmaceuticals, LLC

Sold / distributed

Nationwide to medical facilities.

Why it was recalled

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1