The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0731-2017·Announced 2017-05-24

Key Pharmacy Recalls PGE1 Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling PGE1 MDV 20mcg/mL injections due to a lack of assurance of sterility. The affected products were 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving potential sterility issues.

Plain-English summary

Key Pharmacy and Compounding Center is recalling PGE1 MDV 20mcg/mL injections, which are prescription-only sterile compounded drugs. The recall is being conducted because the firm cannot assure the sterility of the products within their expiration dates.

The affected products are packaged in 5 mL, 10 mL, and 15 mL glass multiple-dose vials. The recall includes specific lots with expiration dates of July 5, 2017, and August 2, 2017. These products were distributed nationwide in the United States, as well as in Australia and Canada.

Consumers and healthcare providers should stop using the affected PGE1 MDV 20mcg/mL injections and contact their healthcare provider or the recalling firm for further instructions on how to return or dispose of the product.

The recalled product

Product
PGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL, Rx only, packaged in a 5 mL, 10mL, and 15 mL Glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard

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 (6)

  • Lot # t01-05-2017@102
  • Exp 7/5/2017
  • t02-02-2017@105
  • Exp 8/2/2017
  • t02-10-2017@121
  • Exp 8/2/2017.

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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