D-1189-2022 Class II Terminated
FDA drug recall D-1189-2022 was initiated by Jubilant Draximage Inc on June 16, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing. The recall status is terminated (terminated July 25, 2023). Affected quantity: 519 cartons/30 vials each.
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