7025. Mineral oil. (F.D.C. No. 47156. S. No. 9-876 T.) QUANTITY: 2 55-gal. drums, 9 1-gal. btls., 12 2-gal. btls., 40 1-qt. btls. and 35 1-pt. btls., at Rochester, N.Y., in possession of Rochester Drag Cooperative, Inc. SHIPPED: On an unknown date, from Philadelphia, Pa. LABEL IN PART: (Btl.) "Extra Heavy Mineral Oil *** An Intestinal Lubri cant *** Distributed by Rochester Drug Cooperative, Inc. Rochester. N.Y." RESULTS OF INVESTIGATION: The article in the bottles was repacked by the dealer from bulk drums shipped as described above. LIBELED: 2-26-62, W. Dist. N.Y. CHARGE: 502(a)—while held for sale, the repack label contained false and misleading representations that the article was adequate and effective for the treatment of chronic constipation, intestinal disorders, and piles; and 502(f) (2)—the labeling failed to bear adequate warnings against its misuse, since it failed to bear the warnings that the article should be taken only st bedtime, is not for prolonged use, and should not be administered to infants or young children, in pregnancy, or to bedridden or aged patients unless directed by a physician. The article was alleged also to be misbranded under the provisions of the law applicable to foods, as reported in notices of judgment on foods. DISPOSITION: 3-27-62. Consent claimed by Rochester Drug Cooperative, Inc. and relabeled. 7026. Sendol tablets. (F.D.C. No. 46769. S. Nos. 28-217/19 T.) QUANTITY: 59,760 individually ctnd. 100-tablet btls.; 3,631 individually etud 36-tablet btls.; and 155 display ctns., containing 12 12-tablet boxes each, at Kansas City, Mo., in possession of Dayco Laboratories, Inc. SHIPPED: On unknown dates between 1958 and 1961, from Cleveland, Ohio. LABEL IN PART: (Ctn., btl., and box) "Sendol *** Sendol Company, Distributors, Kansas City, Missouri" and (btl. and box only) "Active Ingredients: Aspirin (Acetylsalicylic Acid), caffeine Alkaloid." ACCOMPANYING LABELING: Leaflets entitled "You Will Quickly Feel Better With Sendol." RESULTS OF INVESTIGATION: The article was originally shipped to Sendol Co. Excelsior Springs, Mo., who, in March 1961, sold the name and assets of the company to Dayco Laboratories, Inc. CHARGE: 502(a)—while held for sale, the labeling contained false and s leading representations that the article was adequate and effective for qui à relief of painful disorders due to simple headaches, colds, pains and aches and minor aches and pains of rheumatism, neuritis, sciatica, bursitis, and lumbago; and 502(f) (2)—the labeling failed to bear warnings prescribed by regulations for drug preparations containing salicylates, for use in arthri tis and rheumatism and for over-the-counter drugs for minor sore throats. DISPOSITION: 3-28-62. Consent-claimed by Dayco Laboratories, Inc., and released under bond for relabeling. 7027. Abunda Beauty device. (F.D.C. No. 46640. S. No. 23-719 T.) QUANTITY: 19 cases, each containing 20 individually ctnd. devices, and 4 cases, each containing 23 plastic display units, at Albuquerque, N. Mex. SHIPPED: 10-17-60, from Menlo Park, Calif., by Pam-Pro Plastics. LABEL IN PART: (Case) "From: Pam-Pro Plastics 1075 O'Brien Drive Menlo Park, Calif. To: Joseph Ruffino 3109 San Pedro N.E. Albuquerque, New Mexico Qty. 20 Units Weight 32# 18 of 25" and (ctn.) "Abunda Beauty by Abunda Products 20 Forty First Avenue-San Mateo, California." RESULTS OF INVESTIGATION: Examination showed that the article was a plastic cup-shaped device with a water hose attachment. In use, the cup was intended to be placed over the female breast with the hose attachment connected to the household water service. The water was caused to be diffused or "swirled" in passing through a perforated disc in the cup base and the swirling water within the cup reportedly served to massage the bust. LIBELED: 12-1-61, Dist. N. Mex. CHARGE: 502(a)—when shipped, the name of the device “Abunda Beauty" was false and misleading as applied to the device since such name represented and suggested that the device was beneficial to the development of the female breast, whereas, the device was not beneficial to such development; and 502(f) (1)—the labeling of the article failed to bear adequate directions for use for the purposes for which it was intended, namely, for use on the female breast. DISPOSITION: 1-10-62. Default-destruction. 7028. Abunda Beauty device. (F.D.C. No. 46936. S. No. 23-043 T.) QUANTITY: 98 individually ctnd. devices and 34 plastic display cases at Albuquerque, N. Mex., in possession of James E. Henderson. SHIPPED: 9-7-60, from Menlo Park, Calif., by Pam-Pro Plastics. LABEL IN PART: (Ctn.) "Abunda Beauty by Abunda Products 20 Forty-First Avenue, San Mateo, California"; (display case) "Abunda Beauty" (on sides) and "Abunda Beauty 20 Forty-First Ave. San Mateo, Calif." (on lid). ACCOMPANYING LABELING: Leaflets entitled "Abunda Beauty . . . A Lovelier You" and "Abunda Beauty Basic Concept of Abunda Beauty"; booklets entitled "Abunda Beauty . . . A Lovelier You" and "Abunda Hydro Massage Bosom Beauty." RESULTS OF INVESTIGATION : Examination showed that the article was a plastic cup-shaped device with a water hose attachment. In use, the cup was intended to be placed over the female breast with the hose attachment connected to the household water service. The water was caused to be diffused or "swirled" in passing through a perforated disc in the cup base and the swirling water within the cup reportedly served to massage the bust. LIBELED: 1-24-62, Dist. N. Mex. CHARGE: 502(a)-when shipped and while held for sale, the name "Abunda Beauty" and statements appearing in its labeling, contained false and misleading representations that the article was adequate and effective for awakening and increasing bosom beauty; encouraging bosom perfection; restoring, healing, and revitalizing the tissues of the bosom; increasing circulation of the bust; providing cell nourishment to firm the tissues; and for providing an 678106-63- 3 abundant bust through hydrotherapy; and 502(f) (1)—the labeling failed to bear adequate directions for use for the purposes for which it was intended. namely, for use on the female breast. DISPOSITION: 2-26-62. Default-20 devices and display cases and accompanying labeling were delivered to the Food and Drug Administration; remainder destroyed. 7029. Affinitizer device. (F.D.C. No. 45524. S. No. 68-735 R.) QUANTITY: 1 device at Dallas, Tex., in possession of Mrs. Yuba G. Freeman naturopath. SHIPPED: Sometime during 1952, from Glendale, Calif. ACCOMPANYING LABELING: Booklet entitled "The Diagnometer Seroyal Brands. Inc., Orinda, California." RESULTS OF INVESTIGATION: The inspector's photographs and description indicated the article to be in the form of a hollow plastic block, about 12 inches square and 1 inch thick. On the face of the block is an indicator dial with inscribed numbers ranging from 0 to 270. The unit contains no electrical circuit, but the dial operation is reportedly magnetic. Three plastic strings are taped to the plastic block. For diagnostic purposes, one string is held over the area of the patient's heart, one string is placed in the area of the gland or organ to be checked, and one string is held over the dial of the device. LIBELED: 3-24-62; amended libel 4-26-61, N. Dist. Tex. CHARGE: 502(b) (1)—while held for sale, the article failed to bear a label containing the name and place of business of the manufacturer, packer, or distributor; 502(f) (1)—its labeling failed to bear adequate directions for the purposes for which it was intended, namely, in the treatment of diabetes, and it the diagnosing of the condition of the pituitary, liver, thyroid, and pancreas glands, the purposes for which the article was used by Mrs. Freeman; and 502(a)—when shipped and while held for sale, the labeling accompanying the article, contained false and misleading representations that the article was adequate and effective for diagnosing practically all diseases and conditions including, but not limited to, the following diseases and conditions; pnenmonia, tuberculosis, diphtheria, cancer, malaria, syphilis, trichina, meningitis tapeworm, fibroid tumor, anthrax, kidney stone, gallstone, polio, colitis, tularemia, blood sugar, bronchitis, asthma, rheumatic fever, gastric ulcer, botulism, sinusitis, nephritis, psoriasis, infectious mononucleosis, Vincent's angina. Banti's disease, filariasis, tetanus, hay fever, eczema squamosum, eczema madidans, cirrhosis of the liver, influenza, smallpox, impetigo; and that the article was adequate and effective for (a) determining where spinal adjustments were needed; (b) determining the locations of adhesions in the adbomen; (c) determining whether food contains poison; (d) determining whether the subject's heart and bloodstream are in a normal or subnormal condition; (e) determining the acid-alkaline balance of the body; (f) pointing out the foods which increase vitality in the body and foods which decrease vitality; and (g) pointing out the organs that have succumbed to toxicity and the nature and extent of the disease. DISPOSITION: Mrs. Yuba G. Freeman filed a plea of intervention and, thereafter, the Government filed interrogatories, which were answered by the intervenor. The Government then filed a motion for summary judgment based on the answers to interrogatories. On 2-24-62, the court entered an order granting the motion for summary judgment, condemning the article, and providing for delivery of the device to the Food and Drug Administration. DRUG FOR VETERINARY USE 7030. Turkey Formula Streppenmycin. (F.D.C. No. 46156. S. No. 54-595 R.) QUANTITY: 1 keg containing 18 unlabeled 5-lb. bags at Lone Rock, Wis. SHIPPED: 5-24-61, from Mankato, Minn., by Paul's Products Co. LABEL IN PART: (Keg) "Turkey Formula 100 pounds 20/5# bags * Streppenmycin * As an aid in the control of Streptomycin and Penicillin sensitive bacteria usually present in infectious sinusitis, air sac, or blue comb disease in turkeys. Each pound contains * manufactured by Paul's Products Co. Mankato, Minnesota * Control No. 213 Exp. Directions CHARGE: 502(b)—when shipped and while held for sale, the article failed to bear a label (bag) containing (1) the name and place of business of the manufacturer, packer, or distributor, and (2) an accurate statement of quantity of contents; 502(e) (2)—its label failed to bear the common or usual name of each active ingredient; and 502(f) (1)—the labeling failed to bear adequate directions for use. DISPOSITION: 3-17-62. Default-destruction. DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM OFFICIAL OR OWN STANDARDS DRUGS AND DEVICES FOR HUMAN USE* 7031. Calcium lactate tablets. (F.D.C. No. 47224. S. No. 24-407 T.) QUANTITY: 4 25,000-tablet drums and 1 20,000-tablet drum at Cleveland, Ohio. SHIPPED: 12-6-61, from Worcester, Mass. RESULTS OF INVESTIGATION: Examination showed the presence of moldy tablets. LIBELED: 3-8-62, N. Dist. Ohio. CHARGE: 501 (b)—while held for sale, the article purported to be and was represented as calcium lactate tablets, a drug, the name of which is recognized in the National Formulary, an official compendium, and its quality or purity fell below the standard set forth in such compendium by reason of the presence therein of moldy tablets. DISPOSITION: 4-25-62. Default-destruction. 7032. Trisulfacidin suspension. (F.D.C. No. 47172. S. No. 38-556 T.) SHIPPED: 11-17-61, from St. Louis, Mo., by Organo Pharmaceutical Co. * Each Teaspoon (5 cc.) contains: Sulfadiazine 0.166 Gm. Sulfamerazine 0.166 Gm. Sulfamethazine 0.166 Gm. Pyrilamine Maleate 6.25 mg. Pheniramine MaleSee also No. 7005. ate 6.25 mg. Phenylpropanolamine HCl 12.5 mg. Sodium Citrate 250 mg. Jamieson-McKames Pharmaceuticals, Inc. St. Louis 16, Mo." RESULTS OF INVESTIGATION: Analysis showed that the article contained sulfacetamide and not sulfamethazine. LIBELED: 2-23-62, N. Dist. Ala. CHARGE: 501 (d) (2)—when shipped, sulfacetamide had been substituted in whole or in part for sulfamethazine; and 502(a)—the label statement "Sulfa. methazine 0.166 Gm." was false and misleading as applied to a product which did not contain sulfamethazine. 7033. Adhesive bandages. (F.D.C. No. 45353. S. Nos. 46-231/33 R.) QUANTITY: 2 cases, containing 720 individually wrapped bandages in pkgs. of 10 each, and 1 case, containing 720 individually wrapped bandages in pkgs. of 12 each, at Lancaster, S.C. SHIPPED: 10-6-60, from New Rochelle, N.Y., by Hampton Manufacturing Co. LABEL IN PART: (Pkg.) "Blue Cross Plastic Adhesive Bangages Sterile Hampton Mfg. Co. New Rochelle, N.Y. Plain Pads"; "Waterproof Blue Cross Sterile Adhesive Bandages Hampton Mfg. Co. New Rochelle, N.I. * 'Mercurochrome' Pads H. W. & D. Brand of Merbromin"; and "Blue Cross Plastic Adhesive Bandages Sterile * * * Hampton Mfg. Co. New Rochelle, N.Y. 'Mercurochrome' Pads H. W. & D. Brand of Merbromin." LIBELED: On or about 1-30-61, W. Dist. S.C. CHARGE: 501 (b)-the quality and purity of the article, when shipped, fell below the standard for adhesive absorbent bandage (adhesive absorbent compress) set forth in the United States Pharmacopeia since the article was not sterile but was contaminated with living microorganisms; and 502(a)-the label statement "Sterile" was false and misleading. DISPOSITION: 4-17-62. Default-destruction. 7034. Rubber prophylactics. (F.D.C. No. 47058. S. No. 34-691 T.) QUANTITY: 15 gross cases of individually foil-wrapped prophylactics, packed in boxes of 3, at St. Paul, Minn. SHIPPED: 1-8-62 and 2-5-62, from North Kansas City, Mo., by Dean Rubber Manufacturing Co. LABEL IN PART: (Case) "One Gross 3's No. 10 In Foil Peacocks RediWet *** Dean Rubber Mfg. Co., North Kansas City, Missouri" and (bor of 3) "3 Peacocks Redi-Wet Rubbers in Foil * * An Aid in Preventing Venereal Disease." RESULTS OF INVESTIGATION: Examination showed 4.74 percent of the article was defective in that it contained holes. LIBELED: 2-27-62, Dist. Minn. CHARGE: 501 (c)-when shipped, the quality of the article fell below that which it purported to possess; and 502 (a)—the label statement "An Aid In Preventing Venereal Disease" was false and misleading as applied to an article containing holes. DISPOSITION: 3-13-62. Consent-claimed by Dean Rubber Manufacturing Ce and destroyed. |