NOTICES OF JUDGMENT on Seizure Actions

FOOD / Poisonous and Deleterious Substances

Blood meal, animal feed, at Lynn Center, S. Dist. III.

Charged 10-20-69: when shipped by Midwest Commodities, Inc., Milwaukee, Mich., the article contained the poisonous and deleterious substance Salmonella bacteria; 402(a)(1). Default decree ordered destruction. (1)

FOOD / Contamination, Spoilage, Insanitary Handling

Alcoholic beverages, assorted, at Biloxi, S. Dist. Miss.

Charged 10-9-69: while held by Desert Package Liquor Store, Biloxi, Miss., the articles were held under insanitary conditions in polluted floodwaters; 402(a)(4). Default decree ordered destruction. (2)

Clams, frozen, at Atlanta, N. Dist. Ga.

Charged 9-17-69: when shipped by Howard Johnson's Meat Commissary, Queens Village, N.Y., the article contained decomposed clams; 402(a)(3). Default decree ordered destruction. (3)

Flour, at Los Angeles, C. Dist. Calif.

Charged 9-17-69: while held by California Grocery Trading Co., Los Angeles, Calif., who repacked the article into 100-lb. bags, the article contained insect and rodent filth; 402(a)(3). Default decree ordered destruction. (4)

Nutmeg, at Detroit, E. Dist. Mich.

Charged 10-22-69: when shipped by Murbas Trading Co., New York, N.Y., the article contained insect filth and moldy, decomposed nutmegs; 402(a)(3). Consent decree authorized release to shipper for salvaging. (6)

Peanut granules, at Detroit, E. Dist. Mich.

Charged 10-22-69: when shipped by Aster Nut Products, Evansville, Ind., the article contained insect filth and was prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (7)

Pepper, black, at Gretna, E. Dist. La.

Charged 9-23-69: while held by Zatarain's, Inc., Gretna, La., the article contained insect filth and was held under insanitary conditions; 402(a) (3), 402(a)(4). Consent decree authorized release to dealer for salvaging. (8)

Potatoes, stuffed, frozen, at St. Louis, E. Dist. Mo.

Charged 8-7-69: when shipped by Lafayette Refrigerated Services, Inc., Lafayette, Ind., the article, labeled in part "Holloway House, Inc. Div. J. R. Thompson Co. Chicago, III. Stuffed Baked Potatoes topped with cheddar cheese," contained excessive coagulase positive staphylococci and a high bacterial count and had been prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (9)

Shrimp, breaded, frozen, at Los Angeles, C. Dist. Calif.

Charged 9-11-69: while held by Coral Queen Frozen Foods, Inc., Los Angeles, Calif., the article contained bacterial filth and was prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized release to dealer for salvaging. (10)

Walnuts, black, Blue Ribbon, at Detroit, E. Dist. Mich.

Charged 4-28-69: when shipped by Continental Nut Co., Chico, Calif., the article contained E. coli; 402(a)(3). Consent decree authorized release to A. J. Bellish Co., for salvaging. (11)

Walnuts, black, Blue Ribbon, at Springfield, W. Dist. Mo.

Charged 7-24-69: when shipped by Continental Nut Co., Chico, Calif., the article contained E. coli; 402(a)(3). Consent decree authorized release to shipper for salvaging. (12)

Chub fish, smoked, at Detroit, E. Dist. Mich.

Charged 10-22-69: when shipped by Vita Food Products, Inc., Chicago,
Ill., the article contained the nonconforming food additives DDT and
DDÉ; 402(a)(2)(C). Default decree ordered destruction. (14)

Meat additive, "B.T.", at Portland, Dist. Oreg.

Charged on or about 8-26-69: when shipped by Tender Treat Co., Inc., Spokane, Wash., the article contained the nonconforming food additives sodium bisulfite and sodium sulfite-402(a)(2)(C); and the labeling contained false and misleading representations that the article was suitable and appropriate for use in meat products-403(a). Default decree ordered destruction. (15)

DRUGS / Human Use

Acetaminophen suppositories, at Hialeah, S. Dist. Fla.

Charged 8-12-69: when shipped by Arlo Interamerican Corp. of Puerto
Rico, Hato Rey, P.R., the labeling of the article, labeled in part

"Suppositories Duralgina

Acetaminophen

Distributed by Kessel Laboratories, Inc., Miami, Fla.," failed to bear adequate directions for use; 502(f)(1). Default decree ordered destruction. (16) Chlorpheniramine maleate timed-disintegration tablets, at Norfolk, E. Dist. Va. Charged 1-27-69: when shipped by the American Tablet & Capsule Co., Inc., Brooklyn, N.Y., the labeling of the article, labeled in part "Timed Disintegration Tablets Norhist-8 Chlorpheniramine Maleate 8 mg. U.S.P. Distributed by Norfolk Drug Corp., Norfolk, Virginia," was false and misleading, since the article was not recognized in the United States Pharmacopeia as represented-502(a); and, while held for sale, the article's quality was deficient because of the failure of the tablets of the article to disintegrate completely-501(c). Default decree ordered destruction. (17)

First Aid for Headaches acetaminophen tablets, N.F., at Philadelphia, E. Dist. Pa. Charged 7-30-69: while held by Chex Co., Philadelphia, Pa., who manufactured the article from acetaminophen shipped in interstate commerce, the article's display carton contained false and misleading statements that the article also contained salicylamide, acetophenetidin, and caffeine, when the article did not contain such additional ingredients; and its labeling lacked adequate warnings against administration to children under 3 years of age and against use for more than 10 days unless directed by a physician; 502(a), 502(f)(2). Default decree ordered destruction. (18)

lodine tannic acid complex solution and horse chestnut combination drops, at Hialeah, S. Dist. Fla. Charged 8-12-69: while held for sale after manufacture in Florida from some ingredients shipped in interstate commerce, the article, labeled in part "Yodarsol lodine-Tannic Acid Complex in a sorbitol-sucrose base Distributed by Kessel Laboratories, Inc., Coral Gables, Florida," differed in strength from its purported strength, and lacked adequate directions for use-502(f)(1), 501(c); and the article labeled in part "Fluxine Drops Horse chestnuts extract, Black Haw Bark extract, Nux Vomica tincture Manufactured for Roger Pharmacal Co., Miami 1, Florida" had bottle and carton labeling which contained false and misleading claims for uncomplicated and minor engorgement of veins, uncomplicated hemorrhoids, and painful menstruation; and its label lacked the quantity or proportion of strychnine in the nux vomica of the article-502(a), 502(e)(1)(A)(ii). Default decree ordered destruction. (19)

Kay-Eze analgesic capsules, at Jackson, S. Dist. Miss.

Charged 4-11-69: while held by Kay-Cee Products, Inc., Jackson, Miss., the dealer's labeling contained false and misleading claims for the treatment of arthritis and pain and swelling due to arthritis; 502(a). Consent decree authorized release of the article to dealer for relabeling and permanently enjoined the dealer, its president, Henry N. Brown, and the proposed purchaser of the dealer's business, the Better Business and Industrial Development Corp., Jackson, Miss., from the use of literature or labeling in connection with the promotion and sale of the article representing the article as an adequate and effective treatment for arthritis. (20)

Procto-Biotic rectal ointment, at Coral Gables, S. Dist. Fla.

Charged 7-11-69: while held by Barfred Research Labs., Coral Gables, Fla., who manufactured the article from sulfathiazole and hydrocortisone acetate shipped in interstate commerce, the name and labeling was false and misleading, since the article contained no antibiotic ingredient, and the labeling lacked adequate directions and did not comply with the Rx drug exemption requirement for disclosure of information; 502(a), 502(f)(1). Default decree ordered destruction. (21) Propoxyphene combination tablets, at Plainville, Long Island, E. Dist. N.Y. Charged 11-18-68: when shipped by Milan Pharmaceuticals, Inc., Morgantown, W. Va., the article was a new drug without an effective approved New Drug Application; 505(a). Default decree ordered destruction. (22) Stramonium combination cigarettes for asthma paroxysms, at Chattanooga, E. Dist. Tenn.

Charged 8-26-69: when shipped by Calotabs Co., Inc., Daytona Beach,
Fla., the article, labeled in part "Blosser's Cigarettes The Blosser

Cigarette Company Sole Distributors, Daytona Beach, Florida," was a
prescription drug, and it failed to bear the prescription legend; 503(b)(4).
Default decree ordered destruction. (23)

Trihista-Phen, Tri-Histrin, and Tri-Histin Expectorant antihistamine liquids, Dizymes enzyme capsules, and Estrosan estrogen tablets, at Santa Barbara and Goleta, C. Dist. Calif.

Charged 8-27-69: while held by Recsei Laboratories (who had packed the articles) at Santa Barbara, Calif., the antihistamine liquids lacked warning statements concerning drowsiness-502(f)(2); the Tri-Histin Expectorant antihistamine liquid also lacked warning statements concerning use of phenylephrine and phenylpropanolamine HCI by individuals with high blood pressure, heart disease, diabetes, or thyroid disease-502(f) (2); Tri-Histin antihistamine liquids lacked adequate directions for use for "allergic conditions"-502(f)(1); the Trihista-Phen antihistamine liquid differed from its labeled strength, since it contained approximately 20 percent excess of glyceryl guaiacolate, methapyrilene HCI, pyrilamine maleate, and phenylpropanolamine HCI-501(c); and the 10-mcg. Estrosan tablets had labeling which contained false and misleading claims for hyperchloresterolemia, atherosclerosis, post-menopausal syndromes and acne, and lacked the established name of the active ingredient of the article-502(a), 502(e)(1)(A)(i).__ While held for sale at Goleta, Calif., after having been packed by Recsei Laboratories of Santa Barbara, Calif., Dizymes enzyme capsules had labeling which

contained false and misleading claims for trauma; Trihista-Phen and Tri-Histin Expectorant antihistamine liquids were charged as above502(f)(2), 501(c); the 10-mcg. Estrosan tablets had the false and misleading labeling charged above and the 2.5-mcg. Estrosan tablets had labeling which contained false and misleading claims for angina pectoris as well as hypercholesterolemia, atherosclerosis, post-menopausal syndromes and acne-502(a). Default decree ordered destruction. (24) Ultra-Sept Tine germicidal solution, Ultra-Sept Eye Kleen eyewash, and UltraSept oil, at Houston, S. Dist. Tex.

Charged 7-30-69: when shipped by Golden State Supply Co., Los Angeles, Calif., the labeling of the articles lacked adequate directions for use, adequate warnings, and the established name of each active ingredient, and the labeling of the Ultra-Sept oil contained false and misleading therapeutic claims for sunburn, insect bites, and bacterial skin infection; 502(a), 502(f)(1), 502(f)(2), 502(e)(1)(A)(ii). Default decree ordered destruction. (25).

Vanamil liquid antacid, at Kansas City, W. Dist. Mo.

Charged 10-28-69: when shipped by Vicks Chemical Co., Div. of Richardson-Merrell, Inc., Philadelphia, Pa., the article was a new drug without an effective approved New Drug Application; 505(a). Default decree ordered destruction. (26)

Yohimbine-testosterone combination capsules, at Hialeah, S. Dist. Fla.

Charged 8-12-69: when shipped by Lit Drug Co., Newark, N.J., the article was a new drug without an effective approved New Drug Application; 505(a). Default decree ordered destruction. (27)

DRUGS / Veterinary

Mastitis antibiotic syringes and calcium-dextrose injectable, at Jacksonville, M. Dist. Fla.

Charged 5-26-69: while held for sale, the quality of the syringes fell below purported quality and the label of the syringes lacked an accurate statement of the quantity of contents, since they were approximately 7 percent deficient, they showed evidence of leakage from the plunger and only approximately 87 percent of the antibiotic could be extruded through the syringe-501(c), 502(b)(2); and when shipped by Performance Products, Inc., St. Louis, Mo., the calcium-dextrose injectable, labeled in part "Calcium-Dextrose with Magnesium-Phosphorus Mfd. for Southeastern Laboratories, Inc. Jacksonville 3, Florida," lacked adequate directions for use and was not exempted therefrom, since it was not safe for its intended intraperitoneal administration in horses, except under veterinary supervision, and the labeling lacked the veteri. nary legend restricting its sale-502(f)(1). Default decree ordered destruction. (28)

Yellow Marker sterile veterinary solution, at Hialeah, S. Dist. Fla.

Charged 12-19-69: when shipped by Curts Labs., Inc., Kansas City, Mo., and while held by Professional Veterinary Services, Inc., Hialeah, Fla., the article was a new animal drug without an effective approved New Animal Drug Application, the labeling lacked adequate directions and warnings and the article was an imitation of another drug, D.N.P. Disophenol Parenteral; 501(a)(5), 502(f)(1), 502(f)(2), 502(1)(2). Default decree ordered destruction. (29)

MEDICAL DEVICES

Life-guard Oxygen-resuscitator mask, at Miami, S. Dist. Fla.

Charged 11-25-69: when shipped by Life Aid Products, Ltd., Toronto, Ontario, Canada, the labeling which represented that the article contained 15 to 20 minutes of medical oxygen for emergency first aid was false and misleading, since the amount of available oxygen was not sufficient to maintain a proper supply of oxygen for 15 to 20 minutes, the labeling lacked adequate directions for the intended uses, and lacked adequate warnings; 502(a), 502(f)(1), 502(f)(2). Default decree ordered destruction. (30)

Respirator, at Jackson, S. Dist. Miss.

Charged 7-7-69: when shipped by Crown Products Co., Cleveland, Ohio, the article, labeled in part "Res-Q-Aire Emergency Respirator Machsa, Inc. Cleveland, Ohio 44101," bore the name "Res-Q-Aire" and statements on the carton label and attached card which were false and misleading as to the adequacy and effectiveness of the article as to means of resuscitation; the labeling lacked adequate directions for use, and such could not be written, since the article was neither effective nor safe for its intended purpose; the labeling lacked warnings against use involving obstructions, aspirated objects and dentures, and involving infants or children where the volume of air would be excessive; and the article was dangerous to health when used as directed by its labeling; 502(a), 502(f)(1), 502(f)(2), 502(j). Default decree ordered destruction. (31)

PROPHYLACTICS

Rubber prophylactics, Aztec, at Fort Worth, N. Dist. Tex.

Charged 9-5-69: when shipped by Barnetts, Inc., Charlotte, N.C., the article's quality was deficient and the labeling was false and misleading, since the article contained holes; 501(c), 502(a). Default decree ordered destruction. (32)

COSMETICS / Beauty Products

Clayton's Scalp Good hair preparation, Perfect Four bergamot hair conditioner, Indian Maid Beauty Sage and Sulphur dandruff compounds, and Cherokee Sage and Sulphur dandruff compound, at Clayton, E. Dist. N.C. Charged 8-6-69: while held by Woodrow Russell Beard, t/a Clayton Products Manufacturing Co., Clayton, N.C., who manufactured the articles from active ingredients shipped in interstate commerce, the labeling of the Scalp Good preparation and Perfect Four bergamot conditioner contained false and miseading claims for the treatment and prevention of hair and scalp problems-602(a); the labeling of the Indian Maid Beauty compound (green and white labeled article) and the labeling of the Cherokee compound were false and misleading, since the articles did not contain an amount of sulphur which was of significant

value for the articles' intended purposes, the labeling contained false and misleading claims for treatment of scalp problems, and the labeling lacked adequate warnings to discontinue use and consult a physician if undue skin irritation develops or increases-502(a), 502(f)(2); and the labeling of the Indian Maid Beauty compound (red and yellow labeled article) was false and misleading, since the article did not contain an amount of sulphur which was of significant value for the article's intended purpose, and the labeling lacked adequate directions for use and warnings to discontinue use and consult a physician if undue skin irritation develops or increases-502(a), 502(f)(1), 502(f)(2). Consent decree authorized release to dealer for relabeling. (33)

HAZARDOUS SUBSTANCES

Bondrite contact cements and a cement solvent, at Lemont, N. Dist. III. Charged 7-8-69: when shipped by UBS Chemical Co., Div. of A. E. Staley Manufacturing Co., Cambridge, Mass., the cement solvent, labeled in part "Conolite Solvent for Contact Cement Conolite Division, Woodall Industries Inc., Carpenterville, Illinois," and the contact cements were extremely flammable substances, and lacked a number of the required conspicuous label statements-2(p)(1) [except the solvent], E, F & 1); and the labels of the cements also contained the statement, "Although this adhesive is no hazardous than dry cleaning fluids or gasoline," that negated and disclaimed the required statements-2(p)(1). Default decree ordered destruction. (34)

more

Cherry Bombs, M-80 firecrackers, and Super Bulldog salutes, at Canby, Dist. Oreg.

Charged 5-9-68: when shipped by New Jersey Fireworks Manufacturing Co., Inc., Vineland, N.J., the articles were banned hazardous substances, since they were toys which were flammable solids and generated pressure through explosion when ignited; 2(q)(1)(A). Consent decree authorized release to R. M. Weygandt, t/a Western Fireworks Co., Canby, Oreg., for relabeling and disposal as pest control bombs. (35) Con-Bond contact cement, at Denver, Dist. Colo.

Charged 6-13-69: when shipped by Columbia Cement Co., Inc., Brooklyn, N.Y., the article was extremely flammable and it lacked a number of the required conspicuous label statements; 2(p)(1)(E, F & I). Default decree ordered destruction. (36)

Vinyl-Top-Kote Kit, at Detroit, E. Dist. Mich.

Charged 4-16-69: while held by King Chemical & Equipment Co., Detroit, Mich., after having manufactured the article from lacotene shipped in interstate commerce, the article was flammable, and presented a special hazard by reason of its petroleum distillate content, and lacked required conspicuous label statements; the signal word "Danger" and the statement of hazard "Harmful or Fatal if Swallowed" were inconspicuous, since they did appear on the main panel of the label, and the cautionary statements on the label were inconspicuous, since they did not appear in the required type size and lacked adequate contrast; 2(p)(1)(Ė), 2(p)(2), 3(b). Default decree ordered destruction. (37)

NOTICES OF JUDGMENT on Criminal Actions

FOOD

Anchor Sea Foods Corp., Los Angeles, C. Dist. Calif.

Charged 8-8-69: while held for sale, scallops were exposed to and contaminated with bacterial filth, and were held, prepared, and packed under insanitary conditions; 402(a)(3), 402(a)(4). Guilty plea; fine. (38)

NOTICES OF JUDGMENT on Injunction Actions

Acme Smoked Fish Corp., Arcee Sales Co. (a partnership), Rubin Casiow, corporation vice president and a partner, and Joseph Brownstein, corporation treasurer and a partner, Brooklyn, E. Dist. N.Y. Charged 3-6-67 in complaint for injunction: that the defendants were engaged in receiving fish from sources outside the State of New York and in preparing, smoking, packing, holding, and distributing such fish for human consumption; that when distributed, the fish contained the added poisonous and deleterious substance Salmonella micro-organisms, and had been prepared, packed, and held at the defendants' plant at Brooklyn, N.Y., under insanitary conditions; 402(a)(1), 402(a)(4). Consent decree of permanent injunction enjoined the defendants against the interstate shipment of such violative fish and against the processing and distribution of fish held for sale after shipment in interstate commerce unless and until the defendants' plant was cleaned, specified insanitary conditions in the plant were corrected, and specified sanitary practices, conditions, and procedures were established. (39)

Notices of Judgment are given pursuant to section 705 of the Federal Food, Drug, and Cosmetics Act and section 13 of the Federal Hazardous Substances Act. Notices of Judgment report cases involving seizure proceedings, criminal proceedings, and injunction proceedings. Seizure proceedings are civil actions taken against goods alleged to be in violation, and criminal and injunction proceedings are against firms or individuals charged to be responsible for violations. The cases generally involve foods, drugs, devices, cosmetics, or hazardous substances which were alleged to be adulterated or misbranded or otherwise violative of the law when introduced into and while in interstate commerce, or while held for sale after shipment in interstate commerce.

Notices of Judgment are prepared by Food, Drug, and Environmental Health Division, Office of the General Counsel, DHEW. Published by direction of the Secretary of Health, Education, and Welfare.

Charles C. Edwards, M.D., Commissioner of Food and Drugs Washington, D.C., May 1, 1970

36 May 1970 / FDA Papers