Why it was recalled
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
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 numbers, UPCs & expiration codes
Lot # 1H005, exp. date Nov 30, 2023
Where it was sold
Product was distributed to retailers nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1189-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 16, 2022
- FDA report date
- Jul 20, 2022
- Quantity
- 519 cartons/30 vials each
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Draximage Inc
Original FDA data
Every field from FDA enforcement report D-1189-2022, exactly as published.
Show all FDA fields
- City
- Kirkland
- Status
- Terminated
- Country
- Canada
- Event ID
- 90455
- Address
- 16751 Rte Transcanadienne
- Code information
- Lot # 1H005, exp. date Nov 30, 2023
- Report date
- Jul 20, 2022
- Product type
- Drugs
- Recall number
- D-1189-2022
- Classification
- Class II
- Recalling firm
- Jubilant Draximage Inc
- Product quantity
- 519 cartons/30 vials each
- Termination date
- Jul 25, 2023
- Reason for recall
- Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Product was distributed to retailers nationwide.
- Recall initiation date
- Jun 16, 2022
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2022