HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL Glass/Multiple Dos...
FDA Recall #D-0723-2017 — Class II — April 18, 2017
Product Description
HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/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
240 mL
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # 02-01-2017@38, Exp 4/30/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated