4560. Lions stock remedy. (F. D. C. No. 36831. S. No. 88-875 L.) QUANTITY: 6 33%-lb. drums and 12 125-lb. drums at Centreville, Mich. SHIPPED : 3-30-54, from St. Louis, Mo., by Live Stock Remedy Co. LABEL IN PART: (Drum) "Lions Stock Remedy * * * Directions Inside Worm Seed Mandrake Iron Magnesium & Sodium Sulfate Gentian Ginger Anise Seed Sassafras Blood Root Sulphur Sodium Bi Carl Licorice Senna Asafoetide Potassium Iodide." ACCOMPANYING LABELING: Circular designated "Lions Stock Remedy Made Since 1888 Directions." LIBELED : 6-9-54, W. Dist. Mich. CHARGE: 502 (a)—the accompanying labeling of the article when shipped con- tained false and misleading representations that the article was an adequate and effective treatment for white scours of pigs and calves and for restoring shoats to a normal, healthy condition; and, 502 (f) (1)—the labeling failed to bear adequate directions for use since the labeling recommended use of the article for hogs, cows, cattle, horses, sheep, dogs, cats, poultry, turkeys, and chicks, but failed to state the conditions or purposes for which the article was intended to be given to such animals. DISPOSITION: 7-15-54. Consent—claimed by Live Stock Remedy Co. and relabeled. INDEX TO NOTICES OF JUDGMENT D. D. N. J. NOS. 4541 TO 4560 PRODUCTS N. J. No. Alpha-estradiol tablets *4541 -tocopherol 4547 tocopheryl acetate 4547,4548 Arthritis, remedies for. See Rhematism, remedies for. N. J. No. B-amino-complex tablets 4543, 4549-4555 Bath oil, pine needle 4557 Bursitis, remedies for. See Rheu- matism, remedies for. 1 (4541) Prosecution contested. The cases reported herewith were instituted in the United States district courts by United States attorneys, acting upon reports submitted by the Department of Health, Education, and Welfare. They involve drugs which were adulterated or misbranded within the meaning of the Act while held for sale after shipment in interstate commerce. These cases involve (1) seizure proceedings which were terminated with the entry of default or consent decrees of condemnation and (2) criminal proceedings which were terminated with pleas of guilty or nolo con- tendere. The seizure proceedings are civil actions taken against the goods al- leged to be in violation, and the criminal proceedings are against the firms or individuals charged to be responsible for violations. Similar actions with respect to products alleged to be in violation at the time of shipment are reported in other supplements. Published by direction of the Secretary of Health, Education, and Welfare. GEO. P. LABBICK, Commissioner of Food and Drugs. WASHINGTON, D. C, January 19,1956. CONTENTS* Page New drug shipped without effective application 30 Drug requiring certificate or re- lease, for which none had been issued 31 Drug in violation of prescription labeling requirements 31 Drugs actionable because of failure to bear adequate directions or warning statements 32 Page Drug actionable because of con- tamination with filth 34 Drugs actionable because of devia- tion from official or own stand- ards 34 Drugs and devices actionable be- cause of false and misleading claims 35 Index 41 ?For presence of a habit-forming narcotic without warning statement, see No. 4565;. omission of, or unsatisfactory, ingredients statements, Nos. 4564, 4565; failure to bear a label containing an accurate statement of the quantity of the contents, Nos. 4564-4566;. failure to bear a label containing the name and place of business of the manufacturer^ packer, or distributor, No. 4564. 369875-56 29 Adulteration, Section 501 (a) (1), the article consisted in part of a filthy sub- stance; and, Section 501 (c), the strength of the article differed from that which it purported and was represented to possess. Misbranding, Section 502 (a), the labeling of the article was false and mis- leading; Section 502 (b), the article was in package form and it failed to bear a label containing (1) the name and place of business of the manufacturer, packer, or distributor, and (2) an accurate statement of the quantity of contents; Section 502 (d), the article contained a chemical derivative of barbituric acid, and its label failed to bear the name, and quantity or proportion of such deriva- tive and in juxtaposition therewith the statement "Warning—May be habit forming"; Section 502 (e) (2), the article was not designated solely by a name recognized in an official compendium and was fabricated from two or more in- gredients, and its label failed to bear the common or usual name of each active ingredient; Section 502 (f) (1), the labeling of the article failed to bear adequate directions for use; Section 502 (f) (2), the labeling of the article failed to bear adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users; Section 502 (1), the article purported to be and was represented as a drug composed wholly or partly of a kind of penicil- lin and it was from a batch with respect to which a certificate issued pursuant to Section 507 was not effective; and, Section 503 (b) (4), the article was subject to Section 503 (b)^(l), and its label failed to bear the statement "Caution: Federal law prohibits dispensing without prescription." New drug violation, Section 505 (a), the article was a new drug within the meaning of Section 201 (p), which was introduced into interstate commerce, and an application filed pursuant to Section 505 (b) was not effective with respect to such drug. NEW DRUG SHIPPED WITHOUT EFFECTIVE APPLICATION