Why it was recalled
Failed Stability Specifications
Product description
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.
Lot numbers, UPCs & expiration codes
LOT C2300070 and C2300070E;Exp. May 31, 2025
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0191-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 22, 2024
- FDA report date
- Jan 15, 2025
- Quantity
- 5209 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Draximage Inc., dba Jubilant Radiopharma
Original FDA data
Every field from FDA enforcement report D-0191-2025, exactly as published.
Show all FDA fields
- City
- Kirkland
- Status
- Ongoing
- Country
- Canada
- Event ID
- 95836
- Address
- 16751 Rte Transcanadienne
- Code information
- LOT C2300070 and C2300070E;Exp. May 31, 2025
- Report date
- Jan 15, 2025
- Product type
- Drugs
- Recall number
- D-0191-2025
- Classification
- Class II
- Recalling firm
- Jubilant Draximage Inc., dba Jubilant Radiopharma
- Product quantity
- 5209 kits
- Reason for recall
- Failed Stability Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Nov 22, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 8, 2025