The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0732-2017·Announced 2017-05-24

Key Pharmacy Recalls PGE1 Injection Due to Sterility Assurance Concerns

Key Pharmacy and Compounding Center is recalling PGE1 5ML MDV INJ, 40mcg/mL, due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls are categorized as Severe (Score 4), particularly when involving potential hospitalization or significant injury risks associated with sterility failures.

Plain-English summary

Key Pharmacy and Compounding Center is recalling PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial. The recall is being conducted because the firm lacks assurance of the sterility of the compounded drugs within their expiry date.

The affected product is identified by Lot # t01-06-2017@92 and has an expiration date of 7/5/2017. The quantity involved is 2 vials. The product was distributed nationwide in the U.S.A., as well as in Australia and Canada.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # t01-06-2017@92
  • Exp 7/5/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Key Pharmacy and Compounding Center 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 79 products in this recall →

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