D-1062-2020 Class II Terminated
FDA drug recall D-1062-2020 was initiated by Jubilant Draximage Inc on Mar 19, 2020 and is designated Class II. Reason for recall: Failed Stability Specifications The recall status is terminated (terminated May 19, 2021). Affected quantity: 473 kits of 30 vials.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 1, 2020
- Initiation Date
- Mar 19, 2020
- Termination Date
- May 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 473 kits of 30 vials
Product description
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
Reason for recall
Failed Stability Specifications
Distribution pattern
Product was distributed throughout the United States.
Code information
Lot # 8K143, Exp 10/31/2020.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1062-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026