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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 1H005, exp. date Nov 30, 2023
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Jubilant Draximage Inc
- Reason for Recall:
- Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot # 1H005, exp. date Nov 30, 2023
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1189-2022
Related Recalls
Class I - Dangerous
Failed Stability Specifications
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
Jubilant Draximage
Class I - Dangerous
Labeling: Label Error on Declared Strength