CLASS II ONGOING Drug recall · Reported 15 Jan 2025 · FDA Enforcement Report
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid recalled
Jubilant Draximage Inc is recalling Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection Multi-Dose Reaction, distributed nationwide in the US. The recall was initiated on 22 Nov 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0191-2025
- FDA event ID
- 95836
- Recalling firm
- Jubilant Draximage Inc, Kirkland
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Nov 2024
- FDA classified
- 8 Jan 2025
- Reported
- 15 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Nov 2024 | Recall initiated by company | |
| 8 Jan 2025 | Classified by FDA | +47 days |
| 15 Jan 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide.
Stores named: Costco
Questions about this recall
Is Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection Multi-Dose Reaction recalled?
Yes. Jubilant Draximage Inc recalled Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection Multi-Dose Reaction on 22 Nov 2024. The recall is Class II and its status is Ongoing. Recall number D-0191-2025.
Why was it recalled?
Failed Stability Specifications
Which lots are affected?
LOT C2300070 and C2300070E;Exp. May 31, 2025
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.