The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0734-2017·Announced 2017-05-24

Key Pharmacy Recalls Compounded PGE1/PAP Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of compounded PGE1/PAP injection because the firm cannot assure the sterility of the product.

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: The recall involves a sterile compounded drug with a lack of assurance of sterility, which poses a risk of harm (infection) even though no injuries are reported, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Key Pharmacy and Compounding Center is recalling a specific lot of compounded PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ. The product is a prescription-only injection prepared in 5mL glass multiple-dose vials. The recall involves Lot # t11-16-2016@90, which has an expiration date of 4/19/2017.

The recall was initiated due to a lack of assurance of sterility. The firm is recalling sterile compounded drugs within their expiration date because it cannot guarantee that the product is sterile. The source text does not report any specific illnesses or injuries associated with this recall.

The affected 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/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/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 # t11-16-2016@90
  • Exp 4/19/2017

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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