Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per cart
Summary
The FDA issued a Class II for Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) by Jubilant Draximage Inc. Reason: Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing..
Details
Source
Drug Recall
External ID
D-1189-2022
Action Date
2022-07-20
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot # 1H005, exp. date Nov 30, 2023
Quantity Affected: 519 cartons/30 vials each
Reason for Recall
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Distribution
Product was distributed to retailers nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-16
Company
Kirkland
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 83 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Jubilant Draximage Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jubilant Draximage Inc have FDA actions?
This is the only FDA action we have on record for Jubilant Draximage Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1189-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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