HYDROXO-B12 30ML PBF MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 30 mL Glass/Multiple Dos...
FDA Recall #D-0726-2017 — Class II — April 18, 2017
Product Description
HYDROXO-B12 30ML PBF MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 30 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 # t02-06-2017@102, Exp 4/30/2017; t02-16-2017@106, Exp 4/30/2017.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated