Jubilant Draximage Inc: Drug Recall
Recall #D-1189-2022 · 06/16/2022
Class II: Risk
Recall Details
- Recall Number
- D-1189-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Jubilant Draximage Inc
- Status
- Terminated
- Date Initiated
- 06/16/2022
- Location
- Kirkland, Canada
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 519 cartons/30 vials each
Reason for Recall
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Product Description
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.
Distribution Pattern
Product was distributed to retailers nationwide.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.