GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple ...
FDA Recall #D-0765-2017 — Class II — April 18, 2017
Product Description
GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/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
240 mL
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # 02-20-2017@8, Exp 4/21/2017.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated