Is Technetium tc 99m albumin aggregated kit approved by the US FDA?

Drugs@FDA lists 3 application product lines for Technetium tc 99m albumin aggregated kit, including TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT (Prescription); MACROTEC (Discontinued); PULMOLITE (Discontinued).

Are there safety signals or safety updates for Technetium tc 99m albumin aggregated kit?

US FDA: 1 entry (latest 2023-12-01).

Active substance

Technetium tc 99m albumin aggregated kit

US FDA 3
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT	N/A	injectable · injection	DRAXIMAGE	Prescription	30 Dec 1987
MACROTEC	N/A	injectable · injection	BRACCO	Discontinued	23 Feb 1976
PULMOLITE	N/A	injectable · injection	JUBILANT DRAXIMAGE	Discontinued	16 Nov 1976

Safety signals and safety-related labeling changes

US FDA 1 Dec 2023 TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT — safety-related labeling change
Labeling sections changed: Patient Counseling Information / Patient Information / Medication Guide

All safety entries for technetium tc 99m albumin aggregated kit →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.