D-0227-2023 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

PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 100MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 15MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 30MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML 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

t20221025@7 t20221116@36 20221114@41 t20221117@5 t20221116@36