D-0213-2023 Class II Terminated
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