26957. Adulteration and misbranding of Bismuth Subgallate Comp., Elixir Basham, C. C. T. Quinine Blsulphate, Tincture Aconite Root, V. S. P., Hypodermic Tablets Nitroglycerin, Hypodennio Tablets Strychnine Sulphate, Tincture Hyoscyamus, THE. S. P., Fluid Extract Colchicum Seed, TJ. S. P., Compressed Tablets Cinchophen, Tablet Triturates Mor- phine Sulphate. TJ. S. v. The Tilden Co. Plea of guilty. Fine, $4,000. (F. & D. nos. 34092, 36979. Sample nos. 16877-B, 16887-B, 16889-B, 17408-B, 17411-B, 21432-B, 42209-B, 67858-A, 69660-A. 69666-A.) The Elixir Basham, Tincture Aconite Root, U. S. P., Tincture Hyoscyamus, U. S. P., and Fluid Extract Colchicum Seed, U. S. P. differed from the stand- ards prescribed for them in the United States Pharmacopoeia; the Bismuth Subgallate Comp., contained more bismuth subgallate than the quantity stated on the label, the O. G. T. Quinine Bisulphate, and the Tablet Triturates Morphine Sulphate contained greater quantities of the active principle of each than the quantity stated on the label; and the Hypodermic Tablets Nitro- glycerin, the Compressed Tablets Cinchophen, and the Hypodermic Tablets Strychnine Sulphate contained smaller quantities of the active principle of each than the quantity stated on the label. On May 5, 1936, the United States attorney for the Southern District of New York, acting upon a report by the Secretary of Agriculture, filed in the district court an information against the Tilden Co., New Lebanon, N. Y., charging shipment by said corporation in violation of the Food and Drugs Act, on or about March 23 and 27, April 5, August 30 and 31, October 11, and November 22, 1934, and August 12, 1935, from the State of New York into the State of New Jersey of a quantity each of articles labeled, "Bismuth Sub- gallate Comp.", "Elixir Basham", "O. 0. T. Quinine Bisulphate", "Tincture Aconite Root, U. S. P.", "Hypodermic Tablets Nitroglycerin", "Hypodermic Tablets Strychnine Sulphate", "Tincture Hyoscyamus, U. S. P.". "Fluid Extract Colchicum Seed, U. S. P.", "Compressed Tablets Cinchophen, and "Tablet Triturates Morphine Sulphate", which were adulterated and misbranded. The Bismuth Subgallate Comp. was alleged to be adulterated in that its strength and purity fell below the professed standard and quality under which it was sold, in that it was represented that each fluid ounce of the article contained 8 grains of bismuth subgallate; whereas in fact each fluid ounce of the article contained more than 8 grains of bismuth subgallate, to wit, not less than 14.9 grains. Said article was alleged to be misbranded in that the statement, "Each fluid ounce contains: Bismuth subgallate 8 grs.", borne on the bottle label, was false and misleading in that it represented that each fluid ounce of the article contained 8 grains of bismuth subgallate; whereas in fact each fluid ounce of the article contained more than 8 grains of bismuth subgallate. The Elixir Basham was alleged to be adulterated in that it was sold under and by a name recognized in the United States Pharmacopoeia and differed from the standard of strength, quality, and purity, as determined by the test laid down in said pharmacopoeia, in that 100 cubic centimeters of the article yielded more than 0.8 gram to wit, not less than 1.29 grams of ammonia; whereas said pharmacopoeia provided that Basham's mixture should yield not more than 0.8 gram of ammonia per 100 centimeters; and the standard of strength, quality, and purity of the article was not declared on the container thereof. Said article was alleged to be adulterated further in that it fell below the professed standard and quality under which it was sold, in that it was represented to be Basham's mixture, that is, solution of iron and am- monium acetate, which conformed to the standard laid down in the United States Pharmacopoeia; whereas in fact- the article was not Basham's mixture, that is, a solution of iron and ammonium acetate that conformed to the standard laid down in said pharmacopoeia. Said article was alleged to be misbranded in that the statement "Elixir Basham For Making Basham's Mixture, U. S. P.", borne on the bottle labels, was false and misleading in that it represented that the article was Basham's mixture, that is, a solution of iron and ammonium acetate that conformed to the standard laid down in the United States Pharmacopoeia; whereas in fact it was not Basham's mixture, that is, a solution of iron and ammonium acetate that conformed to the standard laid down in said pharmacopoeia. C. C. T. Quinine Bisulphate, in the form of tablets, was alleged to be adulterated in that its strength and purity fell below the professed standard and quality under which it was sold, in that each of the tablets was repre- sented to contain 3 grains of quinine bisulphate; whereas in fact each of the tablets contained more than 3 grains of quinine sulphate to wit, not less than 4.01 grains. Said article was alleged to be misbranded in that the state- ment, "O. C. T. Quinine Bisulphate", borne on the bottle labels, was false and misleading in that it represented that each of the tablets contained 3. grains of quinine bisulphate; whereas in fact each of the tablets contained more than 3 grains of quinine bisulphate. The Tincture Aconite Root, U. S. P. was alleged to be adulterated in that it was sold under and by a name recognized in the United States Pharma- copoeia and differed from the standard of strength, quality, and purity as determined by the test laid down in said pharmacopoeia, in that the.article, when administered subcutaneously to guinea pigs, had a minimum lethal dose of not less than 0.0012 cubic centimeter for each gram of body weight of guinea pig; whereas said pharmacopoeia provided that tincture of aconite when administered subcutaneously to guinea pigs, should have a minimum lethal dose of not more than 0.00045 cubic centimeter for each gram of body weight of guinea pig; and the standard of strength, quality, and purity of the article was not declared on the container thereof. Said article was alleged to be adulterated further in that its strength and purity fell below the professed standard and quality under which it was sold, in that it was represented to be tincture aconite root that conformed to the standard laid down in the United States Pharmacopoeia; whereas in fact it was not tincture aconite root that conformed to the standard laid down in said pharmacopoeia. Said article was alleged to be misbranded in that the statement "Tincture Aconite Root, U. S. P.", borne on the bottle labels, was false and misleading in that it repre- sented that the article was tincture aconite root that conformed to the stand- ard laid down in the United States Pharmacopoeia; whereas in fact the article was not tincture aconite root that conformed to the standard laid down in said pharmacopoeia. The Hypodermic Tablets Nitroglycerin were alleged to be adulterated in that their strength and purity fell below the professed standard and quality under which they were sold, in that each of the tablets was represented to contain %Q grain of nitroglycerin; whereas in fact each of the tablets contained less than %o grain of nitroglycerin, to wit, approximately so grain. Said ar- ticle was alleged to be misbranded in that the statement, "Tablets Nitroglycerin %o Gr.", borne on the bottle labels, was false and misleading in that each of the tablets was represented to contain %o grain of nitroglycerin; whereas in fact each of the tablets contained less than %o grain of nitroglycerin. The Hypodermic Tablets Strychnine Sulphate were alleged to be adulterated in that their strength and purity fell below the professed standard and quality under which they were sold, in that each of the tablets was represented to con- tain %o grain of strychnine sulphate; whereas in fact each of the tablets con- tained less than %o grain of strychnine sulphate, to wit, approximately %5 grain. Said article was alleged to be misbranded in that the statement, "Tab- lets Strychnine Sulphate %o Gr.", borne on the bottle labels, was false and mis- leading in that it represented that each of the tablets contained %o grain of strychnine sulphate; whereas in fact each of the tablets contained less than %0 grain of strychnine sulphate. The Tincture Hyoscyamus, U. S. P. was alleged to be adulterated in that it was sold under and by a name recognized in the United States Pharmacopoeia and differed from the standard of strength, quality, and purity as determined by the test laid down in said pharmacopoeia, in that 100 cubic centimeters of the article yielded not less than 0.0103 gram of the alkaloids of hyoscyamus; whereas said pharmacopoeia provided that tincture of hyoscyamus should yield from each 100 cubic centimeters not more than 0.0075 gram of the alkaloids of hyoscyamus; and the standard of strength, quality, and purity of the article was not declared on the container thereof. Said article was alleged to be adulterated further in that its strength and purity fell below the professed standard and quality under which it was sold, in that it was represented that the article was tincture of hyoscyamus that conformed to the standard laid down in the United States Pharmacopoeia, and that each 100 cubic centimeters of the article contained 0.007 gram of alkaloids; whereas in fact the article was not tincture of hyoscyamus that conformed to the standard laid down in the United States Pharmacopoeia, and each 100 cubic centimeters of the article contained more than 0.007 gram of alkaloids, to wit, not less than 0.0103 gram. Said ar- ticle was alleged to be misbranded in that the statement, "Tincture Hyoscyamus, U. S. P. * * * Each 100 Cc. contains 0.007 Gm. alkaloids", borne on the bottle labels, was false and misleading in that it represented that the article was tincture of hyoscyamus, that conformed to the standard laid down In the United States Pharmacopoeia, and that each 100 cubic centimeters of the article contained 0.007 gram of alkaloids; whereas in fact the article was not tincture of hyoscyamus that conformed to the standard laid down in the United States Pharmacopoeia and each 100 cubic centimeters of the article con- tained not less than 0.0103 gram of alkaloids. The Fluid Extract Colchicum Seed, U. S. P. was alleged to be adulterated in that it was sold under and by a name recognized in the United States Pharma- copoeia, and differed from the standard of strength, quality, and purity as 163899—87 2 determined by the test laid down in said pharmocopoeia in that it yielded per 100 cubic centimeters not more than 0.196 gram of colchicine; whereas said pharma- copoeia provided that fluidextract of colchicum should yield not less than 0.36 gram of colchicine per 100 cubic centimeters; and the standard of strength, quality, and purity of the article was not declared on the container thereof. Said article was alleged to be adulterated further in that its strength and purity fell below the professed standard and quality under which it was sold in that it was represented to be fluidextract of colchicum seed that conformed to the standard laid down in the United States Pharmacopoeia, to contain 60 percent of alcohol, and to contain in each 100 cubic centimeters 0.4 gram of colchicine; whereas in fact it was not fluidextract of colchicum seed that conformed to the standard laid down in the United States Pharmacopoeia, it contained not more than 51.5 percent of alcohol, and in each 100 cubic centimeters it contained not more than 0.196 gram of colchicine. Said article was alleged to be misbranded In that the statement, "Fluid Extract Colchicum Seed, U. S. P. Alcohol 60 per cent. * * * Each 100 Cc. contains 0.4 6m. Colchicine", borne on the bottle labels, was false and misleading in that the article was represented to be fluldex- tract of colchicum seed that conformed to the standard laid down in the United States Pharmacopoeia, that it contained 60 percent of alcohol, and that it contained in each 100 cubic centimeters 0.4 gram of colchicine; whereas in fact the article was not fluidextract of colchicum seed that conformed to the standard laid down in the United States Pharmacopoeia, it contained not more than 51.5 percent of alcohol, and in 100 cubic centimeters it contained not more than 0.196 gram of colchicine. Misbranding was alleged further in that the article contained alcohol, and the label failed to bear a statement of the quantity or proportion of alcohol contained therein. The Compressed Tablets Cinchophen were alleged to be adulterated in that their strength and purity fell below the professed standard and quality under which they were sold, in that each of the tablets was represented to contain 5 grains of clnchophen, whereas in fact each of the tablets contained less than 5 grains of clnchophen, to wit, not more than 434 grains. Said article was alleged to be misbranded in that the statement "Compressed Tablets Clncho- phen * * * 5 Grains," borne on the bottle labels, was false and misleading in that it represented that each of the tablets contained 5 grains of clnchophen; whereas in fact each of the tablets contained less than 5 grains of clnchophen. The Tablet Triturates Morphine Sulphate was alleged to be adulterated in that its strength and purity fell below the professed standard and quality under which it was sold, in that each of the tablets was represented to contain Ho grain of morphine sulphate; whereas in fact each of the tablets contained more than Ho grain of morphine sulphate, to wit, not less than % grain. Said article was alleged to be misbranded in that the statement, "Tablet * * * Morphine Sulphate Ho Gr.", borne on the bottle labels, was false and misleading in that each of the tablets was represented to contain Ho grain of morphine sulphate; whereas in fact each of the tablets contained more than Ho grain of morphine sulphate, to wit, not less than % grain. On June 29, 1936, the defendant corporation entered a plea of guilty and the court imposed a fine of $4,000. HAEBT L. BROWN, Acting Secretary of Agriculture.