# FDA recall D-200-2013

> **Fresenius Kabi USA LLC (FK USA)** · Class III · drug recall initiated 2013-02-01.

## Product

CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10

## Reason for recall

Labeling: Missing label

## Distribution

Nationwide

## Key facts

- **Recall number:** D-200-2013
- **Recalling firm:** Fresenius Kabi USA LLC (FK USA)
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-02-01
- **Report date:** 2013-03-20
- **Termination date:** 2013-11-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Schaumburg, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-200-2013

## Citation

> AI Analytics. FDA recall D-200-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-200-2013. Source: US FDA. Licensed CC0.

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