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.
Reported: April 16, 2014 Initiated: December 12, 2013 #D-1213-2014
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.
Details
- Recalling Firm
- Zions RX Formulations Services LLC dba RX Formuations Serv.
- Units Affected
- 450 Vials
- Distribution
- AZ
- Location
- Mesa, AZ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zions RX Formulations Services LLC dba RX Formuations Serv.. Units affected: 450 Vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 16, 2014. Severity: Critical. Recall number: D-1213-2014.
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