Kirkland, N/A, Canada
Jubilant Draximage Inc recalls
2 recalls recorded since 2018, most recently on 16 June 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 16 June 2022
- Terminated
- 25 July 2023
- Reason
- Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
- Distribution
- Product was distributed to retailers nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1189-2022
- 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.
Terminated Class II Drugs
- Recall started
- 19 March 2020
- Terminated
- 19 May 2021
- Reason
- Failed Stability Specifications
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1062-2020
- DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc., Kirkland, Quebec, Canada, NDC 65174-288-05, 67175-288-30
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.