D-1189-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 20, 2022
- Initiation Date
- June 16, 2022
- Termination Date
- July 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 519 cartons/30 vials each
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.
Reason for Recall
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Distribution Pattern
Product was distributed to retailers nationwide.
Code Information
Lot # 1H005, exp. date Nov 30, 2023