Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection recall
FDA recall D-0191-2025 · initiated Nov 22, 2024
Jubilant Draximage Inc., dba Jubilant Radiopharma recalled Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection in Nov 2024 — an FDA Class II recall (D-0191-2025) because Failed Stability Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Stability Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5209 kits
Details
- Product
- 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.
- Recalling company
- Jubilant Draximage Inc., dba Jubilant Radiopharma
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Nov 22, 2024
- FDA report date
- Jan 15, 2025
Frequently asked
- Was Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection recalled?
- Jubilant Draximage Inc., dba Jubilant Radiopharma recalled Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection in Nov 2024 — an FDA Class II recall (D-0191-2025) because Failed Stability Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0191-2025 was: Failed Stability Specifications
- Is a recalled Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection are affected?
- Distributed: US Nationwide.. The recall covers these lots — LOT C2300070 and C2300070E;Exp. May 31, 2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0191-2025.