Drug product
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
D-1062-2020
Product summary
- Event
- Event 85226
- Status
- Terminated
- Classification
- Class II
- Quantity
- 473 kits of 30 vials
- Official record key
drug-enforcement:D-1062-2020
Official wording
Reason: Failed Stability Specifications
Code information: Lot # 8K143, Exp 10/31/2020.
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications