# FDA recall D-0228-2023

> **Pharmacy Innovations** · Class II · drug recall initiated 2022-12-22.

## Product

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

## Reason for recall

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

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0228-2023
- **Recalling firm:** Pharmacy Innovations
- **Classification:** Class II
- **Product type:** drug
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0228-2023

## Citation

> AI Analytics. FDA recall D-0228-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0228-2023. Source: US FDA. Licensed CC0.

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