Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx On
Summary
The FDA issued a Class II for Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Mul by Jubilant Draximage Inc., dba Jubilant Radiopharma. Reason: Failed Stability Specifications.
Details
Source
Drug Recall
External ID
D-0191-2025
Action Date
2025-01-15
Status
Ongoing
Category
drug
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/Code Info: LOT C2300070 and C2300070E;Exp. May 31, 2025
Quantity Affected: 5209 kits
Reason for Recall
Failed Stability Specifications
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-22
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Jubilant Draximage Inc., dba Jubilant Radiopharma) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jubilant Draximage Inc., dba Jubilant Radiopharma have FDA actions?
This is the only FDA action we have on record for Jubilant Draximage Inc., dba Jubilant Radiopharma in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0191-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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