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.
Zions RX Formulations Services LLC dba RX Formuations Serv.
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-1213-2014Don't want to check this manually?
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