SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single Dose v...
FDA Recall #D-0780-2017 — Class II — April 18, 2017
Product Description
SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single 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
75 mL
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # 11-29-2016@27, Exp 5/20/2017; 01-25-2017@25, Exp 7/24/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated