Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, R...
FDA Recall #D-1215-2014 — Class II — December 12, 2013
Product Description
Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Reason for Recall
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Recalling Firm
Zions RX Formulations Services LLC dba RX Formuations Serv. — Mesa, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
95 Vials
Distribution
AZ
Code Information
Lot #: 117467@9 Expiration Date: 12/12/2013 Lot #: 117857@2 Expiration Date: 12/15/2013 Lot #: 117740@4 Expiration Date: 12/13/2013
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated