FDA recall D-1213-2014

Product

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.

Distribution

AZ

Key facts

Status

Terminated

Initiation date

2013-12-12

Report date

2014-04-16

Termination date

2014-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mesa, AZ, United States

Primary source

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