Recalls / Class II
Class IID-1062-2020
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
- Affected lot / code info
- Lot # 8K143, Exp 10/31/2020.
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- Jubilant Draximage Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 16751 Rte Transcanadienne, N/A, Kirkland, N/A N/A, Canada
Distribution
- Quantity
- 473 kits of 30 vials
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2020-03-19
- FDA classified
- 2020-03-25
- Posted by FDA
- 2020-04-01
- Terminated
- 2021-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1062-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.