GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL, Rx only, 5mL Plastic/Sin...
FDA Recall #D-0766-2017 — Class II — April 18, 2017
Product Description
GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL, Rx only, 5mL Plastic/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
50 mL
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # t02-20-2017@75, Exp 4/22/2017.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated