HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL Glass/Single Dose vial, Prepar...
FDA Recall #D-0721-2017 — Class II — April 18, 2017
Product Description
HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL 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
50 vials
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # t01-16-2017@91, Exp 4/17/2017; t02-08-2017@93, Exp 4/30/2017.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated