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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Product Detail

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.
Recall Number D-1213-2014
Classification Class I
Code Info Lot #: 117433@15 Expiration Date: 12/07/2013 Lot #: 117446@8 Expiration Date: 12/12/2013 Lot#: 117923@8 Expiration Date: 12/19/2013
Product Distributed Qty 450 Vials
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.

Event Detail

Event Id 67080
Product Type Drugs
Status Ongoing
Recalling Firm Zions RX Formulations Services LLC dba RX Formuations Serv.
City Mesa
State AZ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-12
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern AZ