FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT PHENAPHEN WITH CODEINE NO. 3 (ACETAMINOPHEN; CODEINE PHOSPHATE) ORAL CAPSULES, 325 MILLIGRAMS AND 30 MILLIGRAMS, AND PHENAPHEN WITH CODEINE NO. 4 (ACETAMINOPHEN; CODEINE PHOSPHATE) ORAL CAPSULES, 325 MILLIGRAMS AND 60 MILLIGRAMS, WERE NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, Sept. 3 -- Food and Drug Administration has issued a notice called: Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on Sept. 3 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) has determined that PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 milligrams (mg) and 30 mg, and PHENAP...