Draximage Maa Injection, Powder, For Solution
FDA Recall NDC 65174-270
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Draximage Maa (NDC 65174-270). A significant event, classified as Class II, was initiated on Jun 16, 2022 by Jubilant Draximage Inc. The reported reason for this action was: "Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Jun 16, 2022
Jul 20, 2022
519 cartons/30 vials each
Recall Profile & Regulatory Data
Event ID
90455
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Jubilant Draximage Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to retailers nationwide.
Termination Date
Jul 25, 2023
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.
Batch or Lot Expiration Information
Lot# 1H005, exp. date Nov 30, 2023
Affected Packages Involved in this Recall
65174-270-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
