Class II
Terminated
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
This recall has been terminated (originally issued April 1, 2020).
- Company
- Jubilant Draximage Inc
- Recall Initiated
- March 19, 2020
- Posted
- April 1, 2020
- Recall Number
- D-1062-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 473 kits of 30 vials
- Firm Location
- Kirkland, Canada
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Stability Specifications
Distribution
Product was distributed throughout the United States.
Lot / Code Info
Lot # 8K143, Exp 10/31/2020.
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