FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT RIFADIN (RIFAMPIN) CAPSULES, 150 MILLIGRAMS AND 300 MILLIGRAMS, WERE NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, Aug. 19 -- Food and Drug Administration has issued a notice called: Determination That RIFADIN (Rifampin) Capsules, 150 Milligrams and 300 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on Aug. 19 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) has determined that RIFADIN (rifampin) capsules, 150 milligrams (mg) and 300 mg, were not withdrawn from sale for reasons of safety or effectiveness to the extent that the drugs can be manufactured or formulated in a manner that satisfies any applicable acceptable intake limit for nitrosamine impurities. ...