PYRIDOXAL-5-PHOS 5ML MDV 50MG/ML INJ, 50mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by...
FDA Recall #D-0777-2017 — Class II — April 18, 2017
Product Description
PYRIDOXAL-5-PHOS 5ML MDV 50MG/ML INJ, 50mg/mL, Rx only, 5mL 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
3 vials
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # t02-20-2017@74, Exp 5/22/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated