# FDA recall D-0812-2016

> **Jubilant Draximage Inc** · Class III · drug recall initiated 2016-03-11.

## Product

SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05

## Reason for recall

Labeling: Label Error on Declared Strength

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0812-2016
- **Recalling firm:** Jubilant Draximage Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-03-11
- **Report date:** 2016-04-13
- **Termination date:** 2017-08-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kirkland, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0812-2016

## Citation

> AI Analytics. FDA recall D-0812-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0812-2016. Source: US FDA. Licensed CC0.

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