The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0757-2017·Announced 2017-05-24

Key Pharmacy Recalls PGE1/Procaine Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of PGE1/Procaine injection because the firm cannot ensure the sterile compounded drugs are free from contamination.

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 is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a sterile compounded drug, which poses a risk of harm without reported illnesses.

Plain-English summary

Key Pharmacy and Compounding Center is recalling PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, a prescription-only sterile compounded drug. The recall involves 4 vials from two specific lots: t11-28-2016@86 and t12-19-2016@73, both with an expiration date of 5/22/2017.

The recall was initiated due to a lack of assurance of sterility. The firm is recalling these sterile compounded drugs within their expiry date because it cannot guarantee that the product is free from microbial contamination.

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/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
4

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 (3)

  • Lot # t11-28-2016@86
  • Exp 5/22/2017
  • t12-19-2016@73

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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