TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Mult...
FDA Recall #D-0744-2017 — Class II — April 18, 2017
Product Description
TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/1mg/mL, Rx only, 5 mL 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
3 vials
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # t12-01-2016@93, Exp 5/22/2017; t02-02-2017@100, Exp 8/2/2017.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated