DRUGS ACTIONABLE BECAUSE OF CONTAMINATION WITH FILTH 5563. Saccharin tablets and vitamin B1 tablets. (F.D.C. No. 40602. S. Nos. 47-475 M, 59-895 M.) INFORMATION FILED: 10-15-57, Dist. N.J., against Lit Sales Co., Inc., Newark, N.J., and Stuart W. Lazarus, president. SHIPPED: Between 6-4-56 and 6-28-56, from the State of New Jersey into the States of Illinois and New York. LABEL IN PART: (Btl.) "1000 4 Grain Saccharin Tablets Effervescent Lit Drug Company Newark, N.J. Distributor" and "100 Tablets Vitamin B-12 25 mcg." CHARGE: 501 (a) (1)—contained rodent hairs, fibers, bristles, and nondescript dirt; and 501 (a) (2)—prepared under insanitary conditions. PLEA: Guilty. DISPOSITION: 5-9-58. Each defendant fined $1,000. DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM OFFICIAL OR OWN STANDARDS* 5564. Digitoxin tablets. (F.D.C. No. 40546. S. No. 62–191 M.) QUANTITY: 35 1,000-tablet btls., 178 100-tablet btls., and 1 unlabeled drum containing 102,500 tablets at New York, N.Y. SHIPPED: Digitoxin powder was shipped on 5-17-56, from Paris, France. LABEL IN PART: (Btl.) "Bryant * *Tablets Digitoxin USP 0.2 Mg." RESULTS OF INVESTIGATION: The digitoxin powder, which was shipped as described above, was used to prepare the digitoxin tablets. Examination showed that the tablets contained not more than 83.1 percent of the declared amount of digitoxin. CHARGE: 501 (b)-the strength of the article, while held for sale, differed from the standard for digitoxin tablets set forth in the United States Pharmacopeia since the article contained less than 90 percent of the labeled amount of digitoxin. DISPOSITION: 10-9-57. Default-destruction. 5565. Digitoxin tablets. (F.D.C. No. 40196. S. No. 68-398 M.) QUANTITY: 1 drum of 99,800 tablets at New York, N.Y. SHIPPED: Digitoxin powder was shipped on 3-8-56 and 11-16-56 from Paris, France. LABEL IN PART: "Digitoxin Tablets Pink 0.1 mg." RESULTS OF INVESTIGATION: The digitoxin tablets were prepared from the powder, which had been shipped as described above. Examination showed that the tablets contained 80.3 percent of the declared amount of digitoxin. LIBELED: 6-5-57, S. Dist. N.Y. See also No. 5562. CHARGE: 501 (b)—the strength of the article, while held for sale, differed from the standard for digitoxin tablets set forth in the United States Pharmacopeia since the article contained less than 90 percent of the labeled amount of digitoxin. DISPOSITION: 10-11-57. Default-destruction. 5566. Digitoxin tablets. (F.D.C. No. 40642. S. No. 68-991 M.) QUANTITY: 50,000 tablets in a bulk container at Long Island City, N.Y. SHIPPED: 1-14-57, from Paris, France. LABEL IN PART: "Digitoxin 0.2 mgm." RESULTS OF INVESTIGATION: The shipment described above consisted of digitoxin powder, which was subsequently used in preparing the above-described tablets. Examination showed that the tablets contained not more than 82 percent of the declared amount of digitoxin. LIBELED: 10-7-57, E. Dist. N.Y. CHARGE: 501(b)—the strength of the article, while held for sale, differed from the standard for digitoxin tablets set forth in the United States Pharmacopeia since the article contained less than 90 percent of the declared amount of digitoxin. DISPOSITION: 11-8-57. Default-destruction. 5567. Soluble saccharin. (F.D.C. No. 40696. S. No. 68–971 M.) QUANTITY: 1 100-lb. drum at New York, N.Y. SHIPPED: From Holland. LIBELED: 10-22-57, S. Dist. N.Y. CHARGE: 501 (b)-when shipped, the quality and purity of the article fell below the standard for soluble saccharin set forth in the United States Pharmacopeia since the article exceeded the heavy metals limit of 20 parts per million prescribed by the standard. DISPOSITION: 11-22-57. Default-destruction. 5568. Chorionic gonadotropin. (F.D.C. No. 40929. S. No. 57–847 M.) QUANTITY: 25 boxes, 2 vials each, at Atlanta, Ga. SHIPPED: 7-25-57, from Los Angeles, Calif. LABEL IN PART: "Chorionic Gonadotropin 5,000 I.U. tion in Intramuscular Injection" and "10 cc. Vial Gonadotropin." RESULTS OF INVESTIGATION: For Preparation of Solu Diluent for Chorionic Analysis showed that the article contained sub stantially less than 5,000 I.U. of chorionic gonadotropin potency per vial. LIDELED: 10-31-57, N. Dist. Ga. CHARGE: 501 (c)-the strength of the article, while held for sale, differed from that which it purported or was represented to possess; and 502(a)—the label statement "Chorionic Gonadotropin 5,000 I.U." was false and misleading. DISPOSITION: 12-9-57. Default-destruction. $569. Chorionic gonadotropin. (F.D.C. No. 40923. S. No. 67-814 M.) QUANTITY: 7 boxes, 2 vials each, at Tulsa, Okla. SHIPPED: 7-15-57, from Los Angeles, Calif. LABEL IN PART: "10 cc. Vial Diluent for Chorionic Gonadotropin Contains 0.5% Phenol" and "Chorionic Gonadotropin 5,000 I.U. *** For Intra muscular Injection Only." RESULTS OF INVESTIGATION: Analysis showed that the article contained sub stantially less than 5,000 I.U. of chorionic gonadotropin potency per vial. LIBELED: 11-7-57, N. Dist. Okla. CHARGE: 501 (c)-the strength of the article, while held for sale, differed from that which it purported and was represented to possess; and 502(a)—the label statement "Chorionic Gonadotropin 5,000 I.U." was false and misleading. DISPOSITION: 12-2-57. Default-destruction. 5570. Del-Caps. (F.D.C. No. 40851. S. No. 59-057 M.) QUANTITY: 1 drum containing 21,000 capsules, 4 1,000-capsule btls., 8 500capsule btls., and 18 100-capsule btls. at Philadelphia, Pa. SHIPPED: 6-4-57, from Rensselaer, N.Y., by Delmar Pharmacal Corp. the disintegration of the contents throughout a period of 6-10 hours RESULTS OF INVESTIGATION: The capsules in the btls. had been repackaged by the dealer from the above-mentioned bulk drum. Examination showed that the article contained the labeled amount of dextroamphetamine sulfate; that 68 percent of the dextro-amphetamine sulfate ingredient was released within the first 2 hours; and that the entire labeled amount of such ingredient was released within 5 hours. LIBELED: 10-23-57, E. Dist. Pa. CHARGE: 501 (c)—the quality of the article, when shipped, fell below that which it purported and was represented to possess, namely, the capsules of the article failed to disintegrate at a uniform rate over a 6- to 10-hour period; and 502(a)—the label of the article contained a false and misleading representation that the dextro-amphetamine sulfate ingredient of the article would be released at a uniform rate over a 6- to 10-hour period. DISPOSITION: 11-25-57. Default-destruction. 5571. Pyrilamine maleate capsules. (F.D.C. No. 40905. S. No. 68–952 M.) QUANTITY: 20 ctns. at Woodside, N.Y. SHIPPED: 6-19-57, from Philadelphia, Pa., by Lustgarten Laboratories, Inc. LABEL IN PART: "1000 Capsules Timcaps Pyrilamine Maleate 75 Mg. Timed Disintegration Capsule Each Capsule Contains 75 Mg. Pyrilamine Maleate Released gradually and equivalent to 3 doses of 25 mg. over a period of approximately 8 hours *** Control 6668 * * Distributed by Henry Schein Woodside, L.I., N.Y." RESULTS OF INVESTIGATION: Examination showed that the article contained the labeled amount of pyrilamine maleate and that it released 86 percent of its pyrilamine maleate content within 2 hours and 94 percent in 6 hours. LIBELED: 10-29-57, E. Dist. N.Y. CHARGE: 501 (c)—the quality of the article, when shipped, fell below that which it purported and was represented to possess, namely, the capsules of the article failed to disintegrate at a uniform rate over an 8-hour period; and 502(a)— the label statement "Timed Disintegration Capsule Each Capsule Contains 75 Mg. Pyrilamine Maleate Released gradually and equivalent to 3 doses of 25 mg. over a period of approximately 8 hours" was false and misleading as applied to a product which did not release the drug at a uniform rate over a period of 8 hours. DISPOSITION: 12-2-57. Default-destruction. 5572. Gardophen. (F.D.C. No. 40927. S. No. 48–728 M.) QUANTITY: 11 btls. at Chicago, Ill. SHIPPED: 7-15-57, from Philadelphia, Pa., by Garde Drug Co. LABEL IN PART: "One Gallon Garde Gardophen (Elixir Hyoscyamine Comp.) Each 5 cc (1 teaspoonful) contains: Phenobarbital (1⁄4 Gr.). . . . 16.20 mg." RESULTS OF INVESTIGATION: Analysis showed that the article contained 118 per cent of the labeled amount of phenobarbital. LIBELED: 10-31-57, N. Dist. Ill. CHARGE: 501 (c)-the strength of the article, when shipped, differed from that which it was represented or purported to possess since it contained more than the labeled amount of phenobarbital; and 502(a)—the label statement “Each 5 cc (1 teaspoonful) contains: Phenobarbital (1⁄44 Gr.). . . . 16.20 mg." was false and misleading. DISPOSITION: 12-3-57. Default-destruction. 5573. Haltron capsules and Haloplex capsules. (F.D.C. No. 40622. S. Nos. 68981/2 M.) QUANTITY: 4 100-capsule btls. and 1 500-capsule btl. of Haltron capsules and 10 100-capsule btls. of Haloplex capsules at Jersey City, N.J. SHIPPED: 6-6–57 and 6-18-57, from Brooklyn, N.Y., by Halsey Drug Co. LABEL IN PART: "C-1010 Blue Cross *** Haltron Capsules Whole Liver with Ferrous Sulfate" and "C-1011 Blue Cross *** Capsules Haloplex (liver B-12 Iron and Vitamins)." RESULTS OF INVESTIGATION: Analyses showed that the Haltron capsules contained less than 50 percent of the declared amount of thiamine chloride (vitamin B1) and that the Haloplex capsules contained less than 50 percent of the declared amount of vitamin C (ascorbic acid). LIBELED: 9-5-57, Dist. N.J. CHARGE: 501(c)—the strength of the articles, when shipped, differed from that which they purported and were represented to possess, namely, (Haltron capsules) 1.0 mg. of thiamine chloride and (Haloplex capsules) 50 mg. of ascorbic acid; and 502(a)-the statements on the label of the Haltron capsules "Each Capsule Contains * * * Thiamin Chloride 1.0 mg." and on the label of the Haloplex capsules “Each Capsule Contains * * * Ascorbic Acid 50 mg." were false and misleading. DISPOSITION: 10-14-57. Default-destruction. 5574. Colonoid capsules. (F.D.C. No. 40571. S. No. 39-475 M.) SHIPPED: 3-7-57, from Greenville, S.C., by Lamont Laboratories. cetin 2 gr. Caffeine 4 grain Thenylpyramine Hcl 20 mg." RESULTS OF INVESTIGATION: Examination showed that the article contained no salicylamide. LIBELED: 8-21-57, W. Dist. N.C. CHARGE: 501(c)—the strength of the article, when shipped, differed from that which it was represented to possess, namely, salicylamide 21⁄2 grains; and 502(a) the label statement "Each Capsule contains *** Salicylamide 2% grains" was false and misleading as applied to a product which did not contain salicylamide, and the label statement "For the relief of symptoms of *** sinusitis" was false and misleading since the article was not capable of relieving sinusitis. DISPOSITION: 12-4-57. Default-destruction. 5575. Prophylactics (2 seizure actions). (F.D.C. Nos. 40776, 40786, S. Nos. 80178 M, 80-182 M.) QUANTITY: 45 ctns., each containing 12 boxes of 12 units each, and 32 ctns., each containing 48 3-unit boxes, at Minneapolis, Minn. SHIPPED: 2-28-57 and 5-20-57, from New York, N.Y., by Goodwear Rubber Co., Inc. LABEL IN PART: "Premier Prophylactics" and "Aristocrat *** For Prevention of Disease." RESULTS OF INVESTIGATION: tive in that it contained holes. LIBELED: Examination showed that the article was defec 10-10-57 and 10-11-57, Dist. Minn. CHARGE: 501(c)—when shipped, the quality of the article fell below that which it purported to possess; and 502 (a)-the statement on the label of the 45-ctn. lot "Prophylactics" was false and misleading as applied to an article containing holes. DISPOSITION: 12-26-57. Consent-claimed by Akwell Corp., Akron, Ohio, and destroyed. 5576. Prophylactics. (F.D.C. No. 40783. S.No. 84-002 M.). QUANTITY: 14 ctns., each containing 1 gross, at Keo, Ark. LABEL IN PART: "Big Chief Lubricated Prophylactics." RESULTS OF INVESTIGATION: Examination showed that 3.5 percent of the article was defective in that it contained holes. LIBELED: 10-10-57, E. Dist. Ark. CHARGE: 501 (c)--when shipped, the quality of the article 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: 12-16-57. Consent-claimed by Akwell Corp., Akron, Ohio, and destroyed. |