Class III · Low risk
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Subpotent drug
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specifications
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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.
Affected NDC
65174-0179-05
Compare with the code on your package — it is the most precise check available.
Drug: Sulfur
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Technetium Tc 99m Sulfur Colloid Kit NDC 65174-0179 |
Kit | Jubilant DraxImage Inc., dba Jubilant Radiopharma | Rx |
- Recalling firm
- Jubilant Draximage Inc., dba Jubilant Radiopharma
- NDC code
- 65174-179-05
- Origin
- Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0191-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Sulfur recalls
See all
Class II · Moderate risk
Albuterol (Pf/Sulfuric Acid/Dye Free)
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class III · Low risk
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Class II · Moderate risk
Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Sulfur Ointment 10%
Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
Other recalls by Jubilant Draximage Inc., dba Jubilant Radiopharma
All 2024 recalls
Class II · Moderate risk
Draximage MAA
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Class II · Moderate risk
Draximage Dtpa
Failed Stability Specifications
Class III · Low risk
Sodium Iodide I 131 Capsule
Labeling: Label Error on Declared Strength
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