Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Adminis...
FDA Recall #D-1213-2014 — Class I — December 12, 2013
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.
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.
Recalling Firm
Zions RX Formulations Services LLC dba RX Formuations Serv. — Mesa, AZ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
450 Vials
Distribution
AZ
Code Information
Lot #: 117433@15 Expiration Date: 12/07/2013 Lot #: 117446@8 Expiration Date: 12/12/2013 Lot#: 117923@8 Expiration Date: 12/19/2013
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated