CHARGE: 501(c)—the strength of the article, while held for sale, differed from that which it was represented to possess, namely, 2,500 International Units of chorionic gonadotropin potency per vial; and 502(a)—the label statement "When reconstituted with 10 ml. diluent each vial will contain: Chorionic Gonadotropin 2500 IU” was false and misleading. 5590. Chorionic gonadotropin. (F.D.C. No. 41467. S. No. 85-243 M.) QUANTITY: 261 vials at Chicago, Ill. SHIPPED: 10-11-57, from Orange, N.J. RESULTS OF INVESTIGATION: Examination showed that the article contained substantially less than the 2,500 International Units of chorionic gonadotropin potency per vial which it was represented to have. LIBELED: 3-10-58, N. Dist. Ill. CHARGE: 501(c)—the strength of the article, while held for sale, differed from that which it was represented to possess, namely, 2,500 International Units of chorionic gonadotropin potency per vial. 5591. Reserpine injection. (F.D.C. No. 40420. S. No. 72–560 M.) QUANTITY: 2,718 ampuls at Milwaukee, Wis. SHIPPED: 7-5-56, from Detroit, Mich. RESULTS OF INVESTIGATION: Analysis showed that the article contained 83 percent of the declared amount of reserpine. LIBELED: 8-14-57, E. Dist. Wis. CHARGE: 501(c)—the strength of the article, while held for sale, differed from that which it purported or was represented to possess, namely, 2.5 mg. per cubic centimeter; and 502(a)—the label statement "2.5 mg. per cc" was false and misleading as applied to the article, which contained less than the declared amount of reserpine per cubic centimeter. 5592. Cowlserpa tablets. (F.D.C. No. 40994. S. No. 64-348 M.) QUANTITY: 19 1,000-tablet btls. at Buffalo, N.Y. SHIPPED: 7-19-57, from Auburn, Mass., by Cowley Pharmaceuticals. RESULTS OF INVESTIGATION: Examination showed that the article contained 81 percent of the labeled amount of reserpine. LIBELED: 11-18-57, W. Dist. N.Y.; Amended libel, 12-11-57. CHARGE: 501 (c)-the strength of the article, when shipped, differed from that which it purported and was represented to possess; and 502(a)—the label statement "Each Tablet Contains: Reserpine 0.25 mg." was false and misleading. DISPOSITION: 1-15-58. Default-destruction. 5593. Phenobarbital capsules. (F.D.C. No. 41203. S. No. 55-960 M.) QUANTITY: 9,000 capsules in btls. at Muncie, Ind. SHIPPED: 5-3-57, from Philadelphia, Pa., by Richlyn Laboratories. LABEL IN PART: "List No. Time-Sule Phenobarbital 1 Gr. ** sules Control No. 1586." * 1,000 Cap RESULTS OF INVESTIGATION: Examination showed that the article contained not more than 77 percent of the declared amount of phenobarbital. LIBELED: 12-4-57, S. Dist. Ind. CHARGE: 501 (c)-the strength of the article, when shipped, differed from that which it purported and was represented to possess, namely, 1 grain of phenobarbital per capsule; and 502(a)—the label statement "Time-Sule Phenobarbital 1 Gr." was false and misleading. DISPOSITION: 2-28-58. Default-destruction. 5594. Tran-quil-eez tablets. (2 seizure actions). (F.D.C. Nos. 41374, 41375. S. Nos. 57-528 M, 77–788 M.) QUANTITY: 23 pkgs., each containing 6 ctns. enclosing a 30-tablet pill box, at St. Petersburg, Fla., and 43 ctns., each containing 1 pill box, at Miami, Fla. SHIPPED: 9-19-57 and 10-19-57, from Cincinnati, Ohio, by Grandpa Soap Co. and C. S. Dent & Co., Div. Grandpa Soap Co. LABEL IN PART: (Ctn.) "Dent's Tran-quil-eez 30 Tablets *** Each enteric-coated tablet contains: Theobromine Sodium Salicylate 100 mg. Acetylsalicylic Acid 3 gr. Acetophenetidin 2 gr. * * * Distributed by C. S. Dent & Co., Cincinnati 2, Ohio." ACCOMPANYING LABELING: Circulars reading in part "Personal for Women Only Take Free Leaflet" and package insert reading in part "to end those Blue Days*** Dent's Tran-quil-eez." CHARGE: 501 (c)—the strength of the article, when shipped, differed from that which it purported or was represented to possess since it contained a significantly lesser quantity of acetylsalicylic acid (aspirin) than the amount stated on the label; 502 (a)—the label statement "Acetylsalicylic Acid 3 Gr." was false and misleading; 502(a)—the labeling of the article contained false and misleading representations that the article was an adequate and effective treatment for overcoming "nerve-racking pre-menstrual symptoms," overcoming effects such as nervous tension and irritability due to extra fluids which alter the water balance in the brain, overcoming pressure exerted by fluids on various parts of the body which result in a heavy, swelling feeling which robs one of looks and vitality and causes the face to become puffy, the hands and fingers to swell up, and causing pain in the back, legs, and breasts, eliminating "those terrible pressures that make you so uncomfortable, nervous and irritable at the onset of your period," and "preparing the body physiologically for the menstrual period"; and 502(e)(2)—the label of the article failed to bear the common or usual name of the active ingredient listed as acetylsalicylic acid, for which the common or usual name is aspirin. DISPOSITION: 4-9-58 and 4-14-58. Default-destruction. 5595. Del-Caps capsules and Del-Bardex capsules. (F.D.C. No. 41431. S. Nos. 34-042/3 P.) QUANTITY: 1 9,900-capsule drum, 1 49,900-capsule drum, 8 1,000-capsule btls., 7 500-capsule btls., and 42 100-capsule btls., of Del-Caps, and 1. 25,000-capsule drum, 3 500-capsule btls., and 7 100-capsule btls. of DelBarder at Philadelphia, Pa. SHIPPED: 11-5-57 and 11-27-57, from Rensselaer, N.Y., by Delmar Pharmacal Corp. LABEL IN PART: (Drum) "Del-Caps 15 Timed Disintegration Capsule * Each capsule contains 15 mg. of Dextro-Amphetamine Sulfate in a special base that provides for the disintegration of the contents throughout a period of 6-10 hours *** 3259" and "Del-Bardex #2 Timed Disintegration Capsule Each Capsule Contains Dextro-Amphetamine Sulfate 15 Mg. Amobarbital 100 Mg. *** Each capsule contains 15 Mg. of Dextro-Amphetamine Sulfate *** in a special base that provides for the disintegration of the contents throughout a period of about 6-10 hours *** 3100.” RESULTS OF INVESTIGATION: The capsules in the btls. had been repacked from the above-mentioned drums by the consignee after shipment. Analysis showed that the Del-Caps capsules released 94 percent of their dextro-amphetamine sulfate content in 2 hours and that the Del-Bardex capsules released 80 percent of their dextro-amphetamine sulfate content in 2 hours. LIBELED: 2-17-58, E. Dist. Pa. CHARGE: 501(c)—the quality of the articles, when shipped, differed from that which they purported or were represented to possess in that they failed to disintegrate at a uniform rate over a 6- to 10-hour period; and 502(a)— the labels contained false and misleading representations that the dextroamphetamine sulfate content of the articles would be released at a uniform rate over a 6- to 10-hour period. 5596. Del-Bardex capsules. (F.D.C. No. 41491. S. No. 29-803 P.) # QUANTITY: 4 drums containing a total of 98,000 capsules at Jersey City, N.J. CHARGE: 501(c)—the quality of the article, when shipped, fell below that which it purported and was represented to possess since it failed to disintegrate at a uniform rate over a 6- to 10-hour period; and 502(a)—the label statement "disintegration * ** period of about 6-10 hours" was false and misleading. DISPOSITION: 4-28-58. Default-destruction. 5597. S.C. red pyrilamine maleate tablets. (F.D.C. No. 40995. S. No. 80-326 M.) QUANTITY: 1 case containing 10,000 tablets at Minneapolis, Minn. SHIPPED: 8-29-57, from St. Louis, Mo. RESULTS OF INVESTIGATION : Examination showed that the article had a strong odor of acetic acid, contained large cracks in its coating due to bursting, and contained a significant amount of free salicylic acid. LIBELED: 11-22-57, Dist. Minn. CHARGE: 501(c)-the quality of the article, while held for sale, fell below that which it purported and was represented to possess since the tablet coatings were bursting and the aspirin was decomposing. [~^SITION: 1-6-58. Default-destruction. 5598. Pentanitrol tablets. (F.D.C. No. 41389. S. No. 20-962 P.) QUANTITY: 8 500-tablet btls. at Kansas City, Kans. SHIPPED: 1-13-58, from Chicago, Ill., by Kasar Co. LABEL IN PART: "Tablets Pentanitrol Pentaerythritol Tetranitrate 10 Mg." RESULTS OF INVESTIGATION: Examination showed that the article contained 20 mg. of pentaerythritol tetranitrate per tablet. LIBELED: 2-4-58, Dist. Kans. CHARGE: 501(c)-the strength of the article, when shipped, differed from that which it purported and was represented to possess, namely, 10 mg. of pentaerythritol tetranitrate; and 502(a)-the label statement "Pentaerythritol Tetranitrate 10 Mg." was false and misleading. DISPOSITION: 3-18-58. Default-destruction. 5599. Halazone tablets. (F.D.C. No. 41443. S. No. 29-863 P.) QUANTITY: 44 cases, each containing 100 btls., at Brooklyn, N.Y. SHIPPED: About 1955, from Atlanta, Ga. * LABEL IN PART: (Btl.) "100 Water Purification Tablets For Purifying Drinking Water in Canteens * * Halazone N.N.R. *** Each tablet contains 0.004 Gm. (16 grain) of Halazone with sodium borate and chloride." RESULTS OF INVESTIGATION: Examination showed that the article contained from 42 to 73 percent of the labeled amount of halazone. LIBELED: 3-3-58, E. Dist. N.Y. CHARGE: 501 (b)-the strength of the article, while held for sale, differed from the standard for halazone tablets set forth in the National Formulary. DISPOSITION: 3-20-58. Default-destruction. 5600. Triferon iron and vitamin tablets and Triferon compound tablets. (F.D.C. No. 41416. S. Nos. 3-481/2 P.) QUANTITY: 1 drum containing 48,050 Triferon iron and vitamin tablets and 1 drum containing 21,620 Triferon compound tablets at Silver Spring, Md. SHIPPED: Prior to 12-31-54, from Brooklyn, N.Y. RESULTS OF INVESTIGATION: Analysis showed that the Triferon iron and vitamin tablets contained less than 70 percent of the declared amount of vitamin B, and that the Triferon compound tablets contained less than 50 percent of the declared amount of vitamin B, (thiamine Hcl). LIBELED: 2-7-58, Dist. Md. CHARGE: 501 (c)—the strength of the articles, while held for sale, differed from that which they purported and were represented to possess; and 502 (a)—the label statements "Triferon Iron & Vitamin Tablets * * *Each Tablet Contains Thiamin HCl 1.5 mg." and "Triferon CPD *** Each Tablet Contains: * ** Thiamin Hcl 0.5 mg." were false and misleading. DISPOSITION: 4-24-58. Default-destruction. 5601. Beta Foplex, MRT Concentrate. (F.D.C. No. 41417. S. No. 29-843 P.) QUANTITY: 18 btls. at Brooklyn, N.Y. SHIPPED: 12-13-57, from Stamford, Conn., by Marvin R. Thompson, Inc. RESULTS OF INVESTIGATION: Analysis showed that the article contained less than 60 percent of the declared amount of riboflavin. CHARGE: 501(c)—the strength of the article, when shipped, differed from that which it purported and was represented to possess; and 502(a)—the label statement "One cc *** contains: * * *Riboflavin (Vitamin B2) .... 2.0 mg." was false and misleading. DISPOSITION: 3-19-58. Default-destruction. QUANTITY: 264 bottles at Gary, Ind. SHIPPED: 10-30-57, from Nashville, Tenn., by National Co. LABEL IN PART: "Contents 2 Fl. Oz. ** * Pure Imported Olive Oil For Table and Medicinal Use." RESULTS OF INVESTIGATION: Examination of the article disclosed the presence of camphorated oil, a poisonous and deleterious substance. LIBELED: 12-26-57, N. Dist. Ind. CHARGE: 501 (b)-when shipped, the article purported to be U.S.P. olive oil, a drug the name of which is recognized in the United States Pharmacopeia, and the quality of the article fell below the standard for olive oil set forth in the Pharmacopeia. The article was alleged also to be adulterated under the provisions of the law applicable to foods, as reported in notices of judgment on foods. DISPOSITION: 2-11-58. Default-destruction. 5603. Rubber prophylactics. (F.D.C. No. 41311. S. No. 85–133 M.) QUANTITY: 349 ctns., each containing 144 2-unit pkgs., at Chicago, Ill. SHIPPED: 10-11-57, from St. Louis, Mo., by M & M Rubber Co. "Spartans Prophylactics." RESULTS OF INVESTIGATION: Examination showed that 4 out of 216 units ex amined were defective in that they contained holes. LIBELED: 12-30-57, N. Dist. Ill. CHARGE: 501 (c)—the quality of the article, when shipped, fell below that which it purported to possess; and 502 (a)—the label statement "Prophylactics" was false and misleading as applied to an article containing holes. DISPOSITION: 1-21-58. Consent-claimed by M & M Rubber Co. Segregated; 42 gross denatured for use as scrap rubber. 5604. Skin prophylactics. (F.D.C. No. 41005. S. No. 86-518 M.) QUANTITY: 20 gross of prophylactics at North Kansas City, Mo. SHIPPED: 11-6-57, from Chicago, Ill., by Frank G. Karg. LABEL IN PART: "Peacock's Redi-Wet Slip-on Skin." RESULTS OF INVESTIGATION: Examination showed that 16 percent of the article was defective in that it contained holes. LIBELED: On or about 11-21-57, W. Dist. Mo. CHARGE: 501(c)—the quality of the article, when shipped, fell below that which it purported to possess. DISPOSITION: 1-16-58. Default-destruction. 5505. Rubber prophylactics. (F.D.C. No. 40919. S. No. 79-604 M.) QUANTITY: 16 ctns., each containing 7,200 individual rubber prophylactics, at New York, N.Y. SHIPPED: 12-31-56, from Akron, Ohio, by Killashun Sales Division. |