# FDA recall D-1189-2022

> **Jubilant Draximage Inc** · Class II · drug recall initiated 2022-06-16.

## Product

Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufactured for Jubilant Draximage Inc. Kirkland, Canada, NDC 65174-270-30.

## Reason for recall

Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.

## Distribution

Product was distributed to retailers nationwide.

## Key facts

- **Recall number:** D-1189-2022
- **Recalling firm:** Jubilant Draximage Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-06-16
- **Report date:** 2022-07-20
- **Termination date:** 2023-07-25

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1189-2022

## Citation

> AI Analytics. FDA recall D-1189-2022. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/D-1189-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*