Agency classClass IIOur severity:High FDA (Drugs)·D-0234-2023·Announced 2023-02-01

Injectable Prostaglandin E1 Multiple Strengths Recalled for Sterility Concerns

Pharmacy Innovations is recalling multiple strengths of injectable Prostaglandin E1 nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an injectable drug recall classified as FDA Class II with a serious hazard (lack of sterility assurance due to insanitary facility conditions). No illnesses or injuries are reported in the source text. The recall scores as High because injectable drugs represent risk-of-harm products where contamination poses significant potential harm; however, without reported hospitalizations or illnesses, it does not meet the threshold for Severe.

Plain-English summary

Pharmacy Innovations is recalling multiple formulations of injectable Prostaglandin E1 distributed nationwide in the United States. The recall was initiated due to lack of assurance of sterility, following an FDA inspection that revealed insanitary conditions at the company's manufacturing facility located at 2936 W 17th St., Erie, PA.

The recalled products include Prostaglandin E1 in multiple strengths ranging from 17 mcg/mL to 60 mcg/mL in various vial sizes (1 mL and 3 mL). These are prescription injectable medications.

Consumers and healthcare providers who have received these products should stop using them and contact Pharmacy Innovations or consult their healthcare provider about appropriate alternatives. Patients currently using these medications should not discontinue use without medical guidance, but should contact their healthcare provider immediately to discuss their options.

The recalled product

Product: 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)…
Manufacturer: Pharmacy Innovations
Category: Drug — Injectable
Hazard: lack-of-sterility
facility-contamination

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 59 recalled by Pharmacy Innovations under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 59 products in this recall →

Same manufacturer · Pharmacy Innovations

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Same hazard · lack of sterility