Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ, 85205.
Recall Number: D-1213-2014
Firm: Zions RX Formulations Services LLC dba RX Formuations Serv.
Classification: Class I
Status: Terminated
Report Date: 20140416
Initiation Date: 20131212
Termination Date: 20140501
Reason for Recall
Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe.
Product Description
Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ, 85205.