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FDAFDA · Food and drugs·Recall number D-0731-2017

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

Published May 24, 2017 · Recall initiated: April 18, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Key Pharmacy and Compounding Center
Distributor
Distributed nationwide in U.S.A., Australia and Canada.
Lot
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.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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