Drug & medication recalls Moderate risk

Jubilant Draximage Inc., dba Jubilant Radiopharma recalls Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx O…

Recall date
November 22, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0191-2025
FDA classification
Class II
Brand / firm
Jubilant Draximage Inc., dba Jubilant Radiopharma
Sold / distributed
US Nationwide.

Why it was recalled

Failed Stability Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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.

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