Reported Jul 20, 2022 · Terminated
Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per…
Jubilant Draximage Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Jubilant Draximage Inc · 16751 Rte Transcanadienne · Kirkland · N/A
Is this the product you have?
- 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.
- Lot codes and dates
Lot # 1H005exp. date Nov 302023
- Amount recalled
- 519 cartons/30 vials each
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
This product could cause temporary or reversible health problems — stop using it.
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