# FDA recall D-1213-2014

> **Zions RX Formulations Services LLC dba RX Formuations Serv.** · Class I · drug recall initiated 2013-12-12.

## 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

- **Recall number:** D-1213-2014
- **Recalling firm:** Zions RX Formulations Services LLC dba RX Formuations Serv.
- **Classification:** Class I
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-1213-2014. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-1213-2014. Source: US FDA. Licensed CC0.

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