FOOD AND DRUG ADMINISTRATION NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT [Given pursuant to section 705 of the Food, Drug, and Cosmetic Act] 4421-4440 DRUGS AND DEVICES The cases reported herewith were instituted in the United. States district courts by the United States attorneys, acting upon reports submitted by the Department of Health, Education, and Welfare, and include, where indicated, the results of investigations by the Department, prior to the institution of the pro- ceedings. Published by direction of the Secretary of Health, Education, and Welfare. GEO. P. LARBICK, Commissioner of Food and Drugs. WASHINGTON, D. C, August 15,1955. CONTENTS Page New drug shipped without effective application. 378 Drugs requiring certificate or re- lease, for which none had been issued 378 Drug for veterinary use 378 Violative sales of prescription drugs 379 Drugs in violation of prescription labeling requirements 380 Page Drugs actionable because of failure to bear adequate directions or warning statements 381 Drugs actionable because of devia- tion from official or own stand- ards 383 Drugs actionable because of false and misleading claims 384 Index 388 348665?55- 377 EW DRUG SHIPPED WITHOUT EFFECTIVE APPLICATION 4421. Enverm syrup. U. S. v. 120 Cartoned Bottles * * *. (F. D. C. No. 36551. Sample No. 75369-L.) LIBEL FILED : On or about May 5,1954, District of Maryland. ALLEGED SHIPMENT : On or about April 2, 1954, by the Manhattan Drug Co., from Brooklyn, N. Y. PRODUCT : 120 cartoned bottles of Enverm syrup at Baltimore, Md. LABEL, IN PAST: (Carton and bottles) "Enverm Syrup For Pin worms Pre- servatives, Sodium Benzoate 0.1?, Methylparaben 0.1?. Each CC contains the equivalent of 100 mg. Piperazine Hexahydrate * * * 2F1. Ozs." NATURE OF CHARGE: Section 505 (a), the article was a new drug within the meaning of the law, and an application filed pursuant to the law was not effective with respect to the article. DISPOSITION : June 2,1954. Default decree of condemnation and destruction. DRUGS REQUIRING CERTIFICATE OR RELEASE, FOR WHICH NONE HAD BEEN ISSUED