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.
Reported: July 20, 2022 Initiated: June 16, 2022 #D-1189-2022
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.
Reason for Recall
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Details
- Recalling Firm
- Jubilant Draximage Inc
- Units Affected
- 519 cartons/30 vials each
- Distribution
- Product was distributed to retailers nationwide.
- Location
- Kirkland
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Jubilant Draximage Inc. Units affected: 519 cartons/30 vials each.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 20, 2022. Severity: Moderate. Recall number: D-1189-2022.
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