FDA-Drug2014-04-16Class I

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.

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.

Sold states
AZ
Affected count
450 Vials
Manufactured in
5949 E University Dr, N/A, Mesa, AZ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1213-2014

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