5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prep...
FDA Recall #D-0709-2017 — Class II — April 18, 2017
Product Description
5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL 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
3 vials
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # t12-28-2016@113, Exp 6/27/2017.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated