FDA recall D-0213-2023

Product

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

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-12-22

Report date

2023-02-01

Termination date

2024-07-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Erie, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0213-2023