Draximage MAA recall: Endotoxin
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…
Why was Draximage MAA recalled?
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 1H005, exp. date Nov 30, 2023
- Product
- 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…
- Recalling firm
- Jubilant Draximage Inc
- Quantity
- 519 cartons/30 vials each
- Distribution
- Product was distributed to retailers nationwide.
- Recall date
- July 20, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)