SECTIONS of federal FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS REPORTED IN D.D.N.J. NOS. 5621-5640 Adulteration, Section 501 (b), the article purported to be and was represented as a drug, the name of which is recognized in an official compendium (United States Pharmacopeia), and its strength differed from, and its quality and purity fell below, the standard set forth in such compendium; and Section 501(c), the article was not subject to the provisions of Section 501(b), and its strength and quality differed from that which it purported or was represented to possess. Misbranding, Section 502 (a), the labeling of the article was false and misleading; Section 502(b)(2), the article was in package form, and it failed to bear a label containing an accurate statement of the quantity of contents; Section 502 (e), the article was a drug not designated solely by a name recognized in an official compendium, and its label failed to bear (1) the common or usual name of the drug; and (2) the drug was fabricated from two or more ingredients, and its label failed to bear the common or usual name of each active ingredient, including the quantity, kind, or proportion of alcohol contained therein; 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 where its use may be dangerous to health, or against unsafe dosage or methods of duration of administration or application, in such manner and form, as are necessary for the protection of users. 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 DRUGS SHIPPED WITHOUT EFFECTIVE APPLICATION 5621. Clarimycin. (F.D.C. No. 41634. S. No. 8-347 P.) QUANTITY: 880 display cards, each containing 1 btl., at Pittsburgh, Pa. LABEL IN PART: (Btl.) "Contents: 5 Drams Clarimycin Anti-Biotic Acne RESULTS OF INVESTIGATION: The article was regarded as a new drug since it was represented to contain neomycin sulfate and was labeled with directions for use over an extended period of time. CHARGE: 502 (a)—the labeling of the article, when shipped, contained false and misleading representations that the article was an adequate and effective treatment for acne, pimples, blackheads, and stubborn skin infections; and 505(a)-the article was a new drug which may not be introduced into inter state commerce, and an application filed pursuant to the law was not effectiv with respect to such drug. DISPOSITION: 6-20-58. Default-destruction. 5622. Pega Palo. (F.D.C. No. 41618. S. No. 18-288 P.) QUANTITY: 142 cellophane pkgs. at Salt Lake City, Utah. SHIPPED: A portion of the article was transported from Chicago, Ill., in January 1957, by Al Cavey and Dave Farrell, partners in the Pega Palo Sales Co., Salt Lake City, Utah, and a portion of the article was shipped from Chicago, Ill., on 3-1-57, by A-1 Import Co. CHARGE: 502(f) (1)—the labeling of the article, when shipped and while held for sale, failed to bear adequate directions for its used as an aphrodisiac and as a sex rejuvenator, which were the purposes for which the article was intended; and 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: 8-1-58. Default-destruction. DRUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE DIRECTIONS OR WARNING STATEMENTS* 5623. R.D.S. laxative herb. (F.D.C. No. 41495. S. No. 14-969 P.) QUANTITY: 1,386 pkgs. at Louisville, Ky., in possession of R. D. Smith. SHIPPED: At various times, from Cincinnati, Ohio. LABEL IN PART: "Net Contents 1 Oz. *** R.D.S. Laxative Herbs * * Active Laxative Ingredients: Senna, Cascara Sagrada. Inactive Ingredients: Saffron, Uva Ursi, Dandelion, Sarsaparilla, Licorice, China Cassia, Anise Seed, Sassafras Bark of Root, Elder Flowers, Cloves and Salicylic Acid * * * Directions: ** Prepared for R. D. Smith*** Zanesville, Ohio." RESULTS OF INVESTIGATION: R. D. Smith was engaged in vending the product to the public, from a sales booth, on the premises of a retail five-and-dime variety store. LIBELED: 4-10-58, W. Dist. Ky. CHARGE: 502(f) (1)—the labeling of the article, while held for sale, failed to bear adequate directions for use in overcoming worm infestation, indigestion, sour stomach, rheumatism, and for preventing diseases of all types, which were the purposes for which the salesman, R. D. Smith, orally offered the product. DISPOSITION: 6-27-58. Default-destruction. 624. Botanical drugs. (F.D.C. No. 41538. S. Nos. 11-870/81 P, 11-883 P, 11885/97 P, 11-899/914 P, 11-916/38 P.) QUANTITY: 1,000 lbs. of various crude botanical drugs in cans, drums, cloth or paper bags, and boxes, and an unknown quantity of botanical drugs repackaged into boxes and into 2-, 6-, 12-, and 32-oz. btls. at Port Huron, Mich., In possession of W. H. McConnell. The crude botanical drugs consisted of such articles as cascara sagrada, elm, sweetgum, and tamarack barks; horseteil and knottgrasses; red clover tops; shillingia, blue flag, burdock, yellow dock, poke, berberis, mandrake, sassafras, bayberry, turnip, wild gum, and bution snakeroots; mullein, buchu, damiana, strawberry, balmony, and renna leaves; blue vervian, chickweed; lobelia, scouring rush, and boneset herbs; and palmetto berries. HIPPED: Between 12-15-48 and 11-18-57, from Jersey City, N.J. See also No. 5622, LABEL IN PART: (Typical specimens on repacked drugs) "No. 11 for Sugar Diabetes Take two tablespoonfuls three times per day," "No. 12 one teaspoonful every three hours," "No. 14 Cancer Liniment Saturate a cloth and apply twice a day," and "No. 45 Kidney Medicine One teaspoonful in a glass of water. Dose, % morning, noon and night." ACCOMPANYING LABELING: An unknown quantity of loose, printed and typed labels intended for use on the repacked drugs. RESULTS OF INVESTIGATION: The repacked drugs had been prepared by W. H. McConnell, by grinding a portion of the crude botanical drugs into a powder and packing into cardboard boxes of 2-oz. and 8-oz. sizes; by grinding to a powder and capsulating the crude drugs, and then packaging the capsules in boxes of 60 or 100 capsules; and by mixing the crude drugs and cooking them with water, and then bottling the liquid extracts into 2-, 6-, 12-, and 32-ozs. btls. LIBELED: On or about 5-6-58, E. Dist. Mich. CHARGE: 502 (a)—while held for sale, a portion of the labels of the articles contained false and misleading claims for the treatment of cancer, diabetes, sinus infection, "flu," rheumatism, and other serious diseases for which the articles would not be an adequate and effective treatment; 502(b) (2)—none of the labels of the articles bore any statement of the quantity of contents contained therein; 502(e)-the labels of the articles failed to bear (1) the common or usual name of the article, and (2) the common or usual name of each active ingredient contained therein; 502(f) (1)—the labeling of the articles failed to bear adequate directions for use for the purposes for which they were intended, for example, eight of the liquid medicines were intended to be used as "blood purifiers," and their individual labels failed to state the purpose for which they were to be used, and item "No. 12" was intended for use as a "strengthener and growth dissolver," and its label gave no indication for use. DISPOSITION: 6-10-58. Default-some of the drugs were delivered to the Food and Drug Administration and the remainder was destroyed. 5625. Epsom salt. (F.D.C. No. 41525. S. No. 6–979 P.) QUANTITY: 210 cases, 12 boxes each, at Providence, R.I. SHIPPED: 4-9-58, from Boston, Mass., by Atlantic Salt & Chemical Co. (also known as Atlantic Salt Co.). LABEL IN PART: (Box) "Five Pounds Atlantic Clipper Epsom Salt U.S.P. LIBELED: 4-21-58, Dist. R.I. CHARGE: 502(a)—the label of the article, when shipped, contained false and misleading representations that the article was an adequate and effective treat ment for biliousness and other digestive disorders; and 502(f) (2)—the articl was essentially a laxative, and its labeling failed to bear a warning that frequen or continued use may result in dependence on laxatives to move the bowels. DISPOSITION: 6-24-58. Consent-claimed by Atlantic Salt Co. and relabele DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FRO OFFICIAL OR OWN STANDARDS 5626. Posterior pituitary injection. (F.D.C. No. 41625. S. No. 64-360 M.) QUANTITY: 4 ctns., 100 ampuls each, at Pittsburgh, Pa. SHIPPED: 11-11-57, from Tuckahoe, N.Y., by Burroughs Wellcome & Co., Inc. LABEL IN PART: (Ctn. and ampul) "Infundin Posterior Pituitary Injection *** 1 cc. (10 U.S.P. Units)." LIBELED: 3-14-58, W. Dist. Pa. CHARGE: 501 (b)-the strength of the article, when shipped, fell below the standard for the article set forth in the United States Pharmacopeia; and 502(a) the label statement "Posterior Pituitary Injection *** 1 cc. (10 U.S.P. Units)" was false and misleading as applied to the article, the potency of which was substantially less than 10 U.S.P. posterior pituitary units per cubic centimeter. 5627. Pituitary posterior injection. (F.D.C. No. 41612. S. No. 83-304 M.) RESULTS OF INVESTIGATION: Individual vial labels to be affixed by the dealer read in part "10CC Posterior Pituitary Injection *** 20 U.S.P. Units per CC." Also accompanying the article was a loose label which read in part "Borden Laboratories, Inc. *** 500 Vials Posterior Pituitary Extract 20 Units U.S.P. ML." LIBELED: 3-20-58, S. Dist. Ind. CHARGE: 501(b)-the strength of the article, when shipped, fell below the standard for posterior pituitary extract set forth in the United States Pharmacopeia; and 502 (a)—the label statements "Posterior Pituitary Extract 20 Units U.S.P. ML." and "10 CC Posterior Pituitary Injection *** 20 U.S.P. Units Per CC" were false and misleading as applied to the article, the potency of which was substantially less than 20 U.S.P. posterior pituitary units per milliliter or per cubic centimeter. DISPOSITION: 6-27-58. Default-destruction. 5628. Amphetidisin-10 capsules. (F.D.C. No. 41577. S. No. 37-724 P.) SHIPPED: 10-17-57, from Rensselaer, N.Y., by Delmar Pharmacal Corp. LIBELED: 2-13-58, E. Dist. Mo. CHARGE: 501(c)-the quality of the article, when shipped, differed from that which it purported or was represented to possess in that it failed to disintegrate at a uniform rate over a 6- to 10-hour period; and 502(a)—the labeled statement "Timed Disintegration Capsules *** Each Capsule Contains 10 Mg. of Dextro-Amphetamine Sulfate in a Special Base that Provides for Timed Disintegration of the Contents throughout a Period of about 6-10 Hours" was false and misleading. ISPOSITION: 3-12-58. Default-destruction. 5629. Rubber prophylactics. (F.D.C. No. 41635. S. No. 27–865 P.) QUANTITY: 19 gross at Dallas, Tex. SHIPPED: 10-29-57, from Akron, Ohio, by Killashun Sales Div. of the Akwell Corp. LABEL IN PART: (Pkg.) "Silver-Tex One Prophylactic." RESULTS OF INVESTIGATION: Examination of 186 units showed that 1.6 percent were defective in that they contained holes. LIBELED: 4-2-58, N. Dist. Tex. CHARGE: 501(c)—the quality of the article, when shipped, fell below that which it purported to possess; and 502(a)—the label statement "Prophylactic" was false and misleading as applied to an article containing holes. 5630. Trimadine capsules. (F.D.C. No. 41613. S. No. 39-002 P.) QUANTITY: 15 1,000-capsule btls., 3 500-capsule btls., 19 100-capsule btls., and 9 30-capsule btls. at Oakland, Calif. SHIPPED: 10-18-57, from Rensselaer, N.Y. LABEL IN PART: "Trimadine Timed Disintegration Capsules Each Capsule Contains Dextro Amphetamine Sulfate 15 Mg. Thyroid 11⁄2 gr., Atropine Sulfate 180 gr., Acetphenolisatin 0.5 gr., Ascorbic Acid 50 mg., Phenobarbital 14 gr., ** each capsule prepared in a special base to allow the disintegration of the contents throughout a 6-10 hour period." * RESULTS OF INVESTIGATION: Analysis showed that the article released more than 72 percent of dextro-amphetamine sulfate within 2 hours. LIBELED: 3-13-58, N. Dist. Calif. CHARGE: 501 (c)—the quality of the article, while held for sale, differed from that which it purported or was represented to possess in that the article failed to disintegrate at a uniform rate over a 6- to 10-hour period; and 502 (a) — the label statement "Timed Disintegration Capsules *** Each Capsule Prepared in a Special Base to Allow the Disintegration of the Contents Throughout a 6-10 Hour Period" was false and misleading. DISPOSITION: 5-6-58. Default-destruction. 5631. Romper teething lotion. (F.D.C. No. 41347. S. Nos. 49-013 M, 11-868 P.) QUANTITY: 1,140 btls. at Detroit, Mich. SHIPPED: 9-25–56, from Cleveland, Ohio, by H & D Labs, Inc. LABEL IN PART: (Btl.) "Romper Teething Lotion * * * Contains Benzocaine 3 percent Alcohol 25 percent 15 cc." RESULTS OF INVESTIGATION: Analysis showed that the article contained benzyl alcohol, and that it contained, also, more than the declared amount of benzocaine and was 23.3 percent short in the volume of contents declared. LIBELED: 1-9-58, E. Dist. Mich. CHARGE: 501(c)—the strength of the article, when shipped, differed from that which it was represented to possess, namely, 3 percent benzocaine per 15 cubic centimeters; 502 (b) (2)—the label of the article failed to bear an accurate statement of the quantity of contents; and 502(e) (2)—the label of the article failed to bear the common or usual name of each active ingredient, including the quantity, kind, and proportion of any alcohol. DISPOSITION: 6-23-58. Default-destruction. |