Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Dec 22, 2022 (4 years ago)

Pe1/Papav/Phen 20mcg/30mg/2mg/Ml

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

Cause type: Sterility / contamination

A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.

What was recalled

PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/30MCG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT (1ML) 10MCG/30MG/2MG/ML INJECTABLE PE1/PAPAV/PHENT 10MCG/18MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/0.5MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 11.8MCG/18MG/0.6MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 12.2MCG/19.29MG/1.22MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 12.5MCG/24MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 40MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.88MCG/18MG/0.6MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.8MCG/17.44MG/0.64MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.9MCG/17.64MG/0.59MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 50MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 50MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5MCG/15MG/0.5MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 60MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 60MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 70MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 8.3MCG/25MG/0.83MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 80MCG/30MG/3MG (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 10MCG/12MG/1MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 10MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 20MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 20MCG/30MG/4MG/0.4MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 30MCG/30MG/1MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 30MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 40MCG/30MG/4MG/0.4MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 50MCG/30MG/2MG/0.1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 60MCG/30MG/4MG/0.15MG/ML (1ML VIAL) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Recalling firm
Pharmacy Innovations
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0228-2023 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by Pharmacy Innovations

All 2022 recalls
Class II · Moderate risk

Voriconazole 10mg/Ml

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

Terminated Sterility / contamination Pharmacy Innovations D-0243-2023

Other sterility / contamination recalls from 2022

All sterility / contamination recalls