FDAFDA · Food and drugs·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
Published April 1, 2020 · Recall initiated: March 19, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Jubilant Draximage Inc
- Distributor
- Product was distributed throughout the United States.
- Lot
- Lot # 8K143, Exp 10/31/2020.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Canada
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