TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/1mg/mL, Rx only, 5 mL Glass/ Mult...

FDA Recall #D-0735-2017 — Class II — April 18, 2017

Recall #D-0735-2017 Date: April 18, 2017 Classification: Class II Status: Terminated

Product Description

TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/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

2 vials

Distribution

Distributed nationwide in U.S.A., Australia and Canada.

Code Information

Lot # t12-22-2016@102, Exp 6/18/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated