D-1189-2022 Class II Terminated
FDA drug recall D-1189-2022 was initiated by Jubilant Draximage Inc on Jun 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 Jul 25, 2023). Affected quantity: 519 cartons/30 vials each.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 20, 2022
- Initiation Date
- Jun 16, 2022
- Termination Date
- Jul 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1189-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026