FDAFDA · Food and drugs·Recall number D-1213-2014
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.
Published April 16, 2014 · Recall initiated: December 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zions RX Formulations Services LLC dba RX Formuations Serv.
- Distributor
- AZ
- Lot
- Lot #: 117433@15 Expiration Date: 12/07/2013 Lot #: 117446@8 Expiration Date: 12/12/2013 Lot#: 117923@8 Expiration Date: 12/19/2013
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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