PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 11, 2023 Initiated: December 22, 2022 #D-0130-2023

Product Description

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.

Details

Recalling Firm
Pine Pharmaceuticals, LLC
Units Affected
11,453 vials
Distribution
Nationwide to medical facilities.
Location
Tonawanda, NY

Frequently Asked Questions

What product 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. Recalled by Pine Pharmaceuticals, LLC. Units affected: 11,453 vials.
Why was this product recalled?
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 11, 2023. Severity: Moderate. Recall number: D-0130-2023.