FDA recall D-0130-2023

Product

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

Reason for recall

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

Distribution

Nationwide to medical facilities.

Key facts

Status

Terminated

Initiation date

2022-12-22

Report date

2023-01-11

Termination date

2023-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tonawanda, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0130-2023