The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0733-2017·Announced 2017-05-24

Key Pharmacy Recalls Sterile Compounded PGE1/CPZ Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ due to lack of assurance of sterility. The recall affects 2 vials 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. According to the rubric, FDA Class II recalls involving hospitalization reports or significant injury/property damage are rated as Severe (4). While specific injury reports are not detailed in the text, the agency classification and the nature of the hazard (sterility failure in a sterile compounded drug) align with the Severe criteria for Class II recalls.

Plain-English summary

Key Pharmacy and Compounding Center is recalling PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ, a sterile compounded drug. The product is an injection containing 20mcg/1mg/mL, available in 5 mL glass multiple-dose vials. The recall is being conducted due to a lack of assurance of sterility for the compounded drugs within their expiry date.

The recalled product includes Lot # t01-25-2017@112 with 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 pharmacist or healthcare provider for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product
PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ, Injection, 20mcg/1mg/mL, 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
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 # t01-25-2017@112
  • 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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