FDA-Drug2023-01-11Class II

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

Pine Pharmaceuticals, LLC
Hazard

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

Sold states
Nationwide to medical facilities.
Affected count
11,453 vials
Manufactured in
355 Riverwalk Pkwy, N/A, Tonawanda, NY, United States
Products
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

Official notice

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

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