Jubilant Draximage Inc 2022-07-20 Health serious FDA
Health · FDA · Recall #FDA-D-1189-2022
Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg… Recall
Issued July 20, 2022 · Jubilant Draximage Inc
In July 2022, Jubilant Draximage Inc recalled the Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
What you should do
- 1 Stop using Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Jubilant Draximage Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Jubilant Draximage Inc
- Category
- Health
- Recall date
- July 20, 2022
- Units affected
- Not reported
- Sold at
- Product was distributed to retailers nationwide.
- Recall number
- FDA-D-1189-2022
- Made in
- Canada
- Issuing agency
- FDA
In context
- Jubilant Draximage Inc has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.