PROSTAGLANDIN (PE1) 45MCG (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 17MCG/ML (1ML VIAL) INJECTABLE P...
FDA Recall #D-0234-2023 — Class II — December 22, 2022
Product Description
PROSTAGLANDIN (PE1) 45MCG (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 17MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 20MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 22.5MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 23MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 30MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 40MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 44.5MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 45MCG/ML (3ML VIAL) INJECTABLE PROSTAGLANDIN E1 50MCG/ML (1ML VIAL) INJECTION PROSTAGLANDIN E1 60MCG/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.
Recalling Firm
Pharmacy Innovations — Erie, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide in the USA
Code Information
t20221027@29 t20221020@25 t20221109@17 t20221118@8 t20221129@68 t20221027@11 t20221010@24 t20221010@61 t20221005@2 t20221024@22 t20221116@36 t20221004@12
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated