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.

FDA recall notice · announced July 20, 2022 · Jubilant Draximage

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Product was distributed to retailers nationwide.
Lot/code information: Lot # 1H005, exp. date Nov 30, 2023
Quantity: 519 cartons/30 vials each
Status: Terminated
Products in this recall event:
- 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 6517 (D-1189-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.