Why it was recalled
Failed Stability Specifications
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
Lot numbers, UPCs & expiration codes
Lot # 8K143, Exp 10/31/2020.
Where it was sold
Product was distributed throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1062-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 19, 2020
- FDA report date
- Apr 1, 2020
- Quantity
- 473 kits of 30 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Draximage Inc
Original FDA data
Every field from FDA enforcement report D-1062-2020, exactly as published.
Show all FDA fields
- City
- Kirkland
- Status
- Terminated
- Country
- Canada
- Event ID
- 85226
- Address
- 16751 Rte Transcanadienne
- Code information
- Lot # 8K143, Exp 10/31/2020.
- Report date
- Apr 1, 2020
- Product type
- Drugs
- Recall number
- D-1062-2020
- Classification
- Class II
- Recalling firm
- Jubilant Draximage Inc
- Product quantity
- 473 kits of 30 vials
- Termination date
- May 19, 2021
- Reason for recall
- Failed Stability Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Mar 19, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 25, 2020