FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT ZANTAC (RANITIDINE HYDROCHLORIDE) INJECTION, EQUIVALENT TO 25 MILLIGRAMS BASE/MILLILITER, HAS NOT BEEN WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, Dec. 12 -- Food and Drug Administration has issued a notice called: Determination That ZANTAC (Ranitidine Hydrochloride) Injection, Equivalent to 25 Milligrams Base/Milliliter, Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on Dec. 12 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) has determined that ZANTAC (ranitidine hydrochloride (HCl)) injection, equivalent to (EQ) 25 milligram (mg) base/milliliter (mL), has not been withdrawn from sale for reasons of safety or effectiveness to the extent that the drug can be manufactured or formulated in a m...