PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Co...
FDA Recall #D-0732-2017 — Class II — April 18, 2017
Product Description
PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Reason for Recall
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recalling Firm
Key Pharmacy and Compounding Center — Federal Way, WA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2 vials
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # t01-06-2017@92, Exp 7/5/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated