Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administr...
FDA Recall #D-1214-2014 — Class II — December 12, 2013
Product Description
Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, 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
861 Bags
Distribution
AZ
Code Information
Lot #: 117037@3 Expiration Date: 12/13/2013 Lot #: 117899@1 Expiration Date: 01/03/2014 Lot #: 118289@7 Expiration Date: 01/09/2014 Lot #: 118078@56 Expiration Date: 01/03/2014 Lot #:118394@29 Expiration Date: 01/09/2014 Lot #: 118338@10 Expiration Date: 01/09/2014 Lot #: 118056@46 Expiration Date: 01/02/2014
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated