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Recall Observatory FDA recall evidence

Drug 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

D-0731-2017

April 18, 2017

Class II

Product summary

Firm
Key Pharmacy and Compounding Center
Event
Event 76912
Status
Terminated
Classification
Class II
Quantity
5 vials total (2/5 mL vials, 1/10mL vial, and 2/15mL vials)
Official record key
drug-enforcement:D-0731-2017

Official wording

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

Code information: 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 pattern: Distributed nationwide in U.S.A., Australia and Canada.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility