D-0213-2023 Class II Terminated

Recalled by Pharmacy Innovations — Erie, PA

Recall Details

Product Type
Drugs
Report Date
February 1, 2023
Initiation Date
December 22, 2022
Termination Date
July 31, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% (10ML VIALS); GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 48.7%(W/V)/0.67%/0.00067% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Reason for Recall

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Distribution Pattern

Nationwide in the USA

Code Information

t20221116@36 t20221117@11