# FDA recall D-0674-2016

> **Medisca Inc** · Class I · drug recall initiated 2014-02-14.

## Product

CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by Medisca Inc. Plattsburgh, NY 12901, USA, NDC #s: 38779-1186-4 (25 g), 38779-1186-5 (100 g), 38779-1186-8 (500 g), 38779-1186-9 (1 kg).

## Reason for recall

Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.

## Distribution

Nationwide and Australia

## Key facts

- **Recall number:** D-0674-2016
- **Recalling firm:** Medisca Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-02-14
- **Report date:** 2016-02-24
- **Termination date:** 2016-02-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plattsburgh, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0674-2016

## Citation

> AI Analytics. FDA recall D-0674-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0674-2016. Source: US FDA. Licensed CC0.

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