Class II
Terminated
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.
This recall has been terminated (originally issued July 20, 2022).
- Company
- Jubilant Draximage Inc
- Recall Initiated
- June 16, 2022
- Posted
- July 20, 2022
- Recall Number
- D-1189-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 519 cartons/30 vials each
- Firm Location
- Kirkland, Canada
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Distribution
Product was distributed to retailers nationwide.
Lot / Code Info
Lot # 1H005, exp. date Nov 30, 2023
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