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5581. Clarimycin. (F.D.C. No. 41325. S. No. 83-423 M.)
Active ingredients: Neomycin Sulphate, Allantoin."
DISPOSITION: 8-20-58. Consent-destruction.
LIBELED: 1-22-58, E. Dist. Mich.
UN 5531-56203ES OF AMERICA
NOTICES OF JUDGMENT
CHARGE: 505 (a)-the article, when shipped, was a new drug which may not
be shipped in interstate commerce since an application filed pursuant to law
and removal, the court, on 5–16-58, after consideration of the briefs of the
O'SULLIVAN, District Judge: "This cause is before the Court upon motion of
"1) The claimant, Merritt Corporation, claims that its motion has validity
“2) The Government's libel is bottomed upon its claim that the articles sub-
“3) Claimant asserts that the cause pending in the District Court of Penn-
“NOW, THEREFORE, it is hereby Ordered that the motion of Merritt Cor-
On 8–27-58, the claimant having consented, the court entered a decree of
5583. Royal jelly capsules. (F.D.C. No. 40945. S. No. 69-118 M.)
N.Y., in possession of Reid & Cubit, Inc.
two days old after introducing the larvae which gives the most active con-
News Reports on Royal Jelly."
containers and, upon receipt at New York, N.Y., it was repackaged into small
Vials and relabeled by the dealer as above described.
contained false and misleading representations that the article would sexually
plication filed pursuant to law was not effective with respect to the article.
DRUGS IN VIOLATION OF PRESCRIPTION LABELING REQUIREMENTS 5584. Various drugs. (F.D.C. No. 40985. S. Nos. 79-421 M, 79-423/4 M, 79
426/9 M.) QUANTITY: 10 vials of Suavitil benactyzine hydrochloride tablets, 700 tablets
of Belladenal in an unlabeled btl., 1 700-tablet labeled btl. of Doriden, 1 800tablet btl. of Netamine with butabarbital, i 850-tablet btl. of Ritalin, 1 1,000-tablet btl. of Plimasin, and 7 100-tablet btls. of Premarin, at Jersey
City, N.J., in possession of Carl H. Kaplan Sales Co. SHIPPED: Between November 1956 and October 1957, from Rouses Point,
Yonkers, and New York, N.Y. RESULTS OF INVESTIGATION: The articles, except for the Premarin tablets, con
sisted of physicians' samples which the consignee, Carl H. Kaplan Sales Co., had obtained from various drug salesmen, drug firms, and unknown sources, and had transported to Jersey City. All of the articles, including the Premarin
tablets, were repacked and relabeled after receipt by the consignee. LIBELED: 12-2-57, Dist. N.J. CHARGE: 502(b)—while held for sale, the labels of the Suavitil benactyzine
hydrochloride tablets, Belladenal tablets, Doriden tablets, Metamine with butabarbital tablets, and Plimasin tablets failed to bear (1) the name and place of business of the manufacturer, packer, or distributor, and (2) an ac curate statement of the quantity of contents; 502(d)—the Belladenal tablets and Metamine with butabarbital tablets contained chemical derivatives of barbituric acid, and while held for sale, their labels failed to bear the name, and quantity or proportion of such dervative and in juxtaposition therewith the statement "Warning—May be babit forming"; 502(e) (2)—the label of the Belladenal tablets, while held for sale, failed to bear a statement of the quantity or proportion of the alkaloids of belladonna contained therein; 502 (f) (1)—while held for sale, the labeling of the Suavitil benactyzine hydrochloride tablets, Belladenal tablets, Doriden tablets, and Metamine with butabarbital tablets failed to bear adequate directions for use; and 503(b) (4)—all of the articles were drugs subject to 503(b) (1), and the labels of the articles, while held for sale, failed to bear the statement "Caution: Federal law prohibits dispensing without prescription."
The libel alleged also that an article labeled "Obron" was misbranded under the provisions of the law applicable to foods, as reported in notices of judg
ment on foods. DISPOSITION: 1-15-58. Default-destruction.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAILURE TO BEAR
ADEQUATE DIRECTIONS OR WARNING STATEMENTS
5585. Super Protein Formula "90" and Formula "90" Supplement. (F.D.C. No
41434. S. No. 75-649 M.) QUANTITY: 7 pkgs, containing 1 btl. of Super Protein Formula "90" and 1 bti
of Formula "90" Supplement at Phoenix, Ariz. SHIPPED: 7–10–57, from Hollywood, Calif., by Hi-Pro Products Co. LABEL IN PART: (Btl.) "MpDs * Super Protein Formula '90' An aid tu
Weight Reducing Increases Energy - Helps Reduce Weight * * * MpDs i a Balanced Protein Food Supplement Contains No Calories
•See also No. 5684.
(or "360'] tablets” and “Formula '90' Supplement Reducing * * * 15 Capsules * * * an additional aid to weight reducing – to be taken in conjunction with MpDs Super Protein Tablets * * * Each Tablet Contains: Sodium Car
boxy Methyl Cellulose ....8 grains Phenylasitin (conc. Prune) ...0.5 Mg."
Formula "90" Supplement, when shipped, contain false and misleading representations that the articles contained no calories, would burn up extra fat, increase metabolism, and otherwise act as an adequate and effective treatment for obesity; and 502(f) (2)—the Formula "90" Supplement contained an irritant laxative, and its labeling failed to warn that it should not be used when symptoms of appendicitis were present and that frequent or continued
use may result in dependence on laxatives. DISPOSITION: 5-7-58. Default-destruction. 5586. Trim-All capsules. (F.D.C. No. 41453. S. No. 23-306 P.) QUANTITY: 3 drums containing a total of 41,500 capsules at North Hollywood,
Each capsule contains 60 mg. Phenylpropanolamine Hcl. 3 gr. Sodium Case
inate, 50 mg. Ascorbic Acid, 0.5 mg. Acetphenolisatin." RESULTS OF INVESTIGATION: Analysis showed that the article contained 77 per
cent of the labeled amount of phenylpropanolamine Hcl and 64 percent of the labeled amount of ascorbic acid, of which the article released 90 percent of both in 2 hours. The article was intended to be repackaged and relabeled by the consignee as follows: "21 Trim-All Capsules (an Appetite Depressant) Each Trim-All Timed Capsule Contains: Phenylpropanolamine Hcl 60 mg. Sodium Caseinate 3 gr. Dextrose 3 gr. Ascorbic acid 50 mg Acetphenolisatin 0.5 mg. In a specially prepared Timed disintegrating capsule that re
leases the ingredients over a period of approximately eight hours. LIEELED: 3-6-58. S. Dist. Calif. CHARGE: 501 (c)—when shipped, the strength of the article differed from, and
its quality fell below, that which it purported or was represented to possess since it contained less than the labeled amounts of phenylpropanolamine Hcl and ascorbic acid, and it failed to release its ingredients over an 8-hour period; 502 (a)--the label statements of the article, when shipped and while held for sale, namely, “Each capsule contains 60 mg. Phenylpropanolamine Hcl. * 50 mg. Ascorbic Acid” and “Each Trim-All Timed Capsule Contains : Phenylpropanolamine Hcl 60 mg. * * * Ascorbic acid 50 mg. * * * In a specially prepared Timed disintegrating capsule that releases the ingredients over a period of approximately eight hours," were false and misleading; and 502(f) (2)-the article was a laxative, and its labeling, when shipped and while held for sale, failed to warn against use when symptoms of appendicitis are present
and that frequent or continued use may result in dependence on laxatives. DISPOSITION : 3-26–58. Default-destruction. 5587. Salicon tablets. (F.D.C. No. 40953. S. No. 76–626 M.) QUANTITY: 135 100-tablet btls., 61 30-tablet btls., and 60 12-tablet btls. at
SHIPPED: 930_57, from Boston, Mass., by K. A. Hughes Co.
salicylic acid (U.S.P. Aspirin) calcium carbonate and magnesium carbonate." LIBELED: 11-14-57, Dist. Maine. CAARGE: 502(a)—when shipped, the label of the article contained false and
misleading representations that the article was an adequate and effective treatment for nervous tension and sleeplessness; 502(f) (1)—the labeling of the article failed to bear adequate directions for use since, in lieu of a dosage statement for children under 3 years of age, its labeling failed to state that for the 3 year and under age group a physician should be consulted ; and 502 (f) (2)—its labeling failed to bear a warning against misuse by children since its labeling failed to warn that the product should be kept out of reach of
children, DISPOSITION: 1-7-58. Default-destruction, 5588. Zina-Ray oil, inhalers, and Ten Second Rub. (F.D.C. No. 41449. S. No.
24–906 P.) QUANTITY: 1,080 1-02. btls. and 284 3-oz. btls. of Zina-Ray oil, 26 cartons,
each containing 1 gross of inhalers, and 1,065 1-oz. tubes and 265 3-oz. tubes
of Ten Second Rub at Minneapolis, Minn., in possession of William R. Hall. SHIPPED: Between 1-7-58 and 1-21-58, from Chicago, Ill. LABEL IN PART: (Btl.) “Zina-Ray Oil * * * Contains eucalyptus oil, menthol,
pine needle oil, peppermint oil"; (vial) “Inhaler Directions: Insert a few drops of Zina-Ray Oil into the end of inhaler"; and (tube) "Ten Second Rub * *
* Active ingredients: Lanolin, menthol, eucalyptus oil, peppermint oil, and pine needle oil." LIBELED: 3–7-58, Dist. Minn. CHARGE: 502(f) (1)—while held for sale, the labeling of the articles failed to
bear adequate directions for use for the purposes for which they were intended, namely, (Zina-Ra! oil and inhalers) for preventing headache, pain in the gums, neuralgia, deafness, arthritis, rheumatism, formation of crystal deposits in the bones, inflammation of the ear, pneumonia, “fu", and overcoming sinus infection and asthma, and (Ten Second Rub) for overcoming arthritis, rheumatism, and all aches and pains to which the body is subject, which were the purposes for which the articles were recommended orally by William R. Hal
on 1-23-58. DISPOSITION: 421-58. Default-destruction.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM
OFFICIAL OR OWN STANDARDS
5589. Chorionic gonadotropin. (F.D.C. No. 41363. S. No. 68–979 M.)
substantially less than 2,500 International Units of chorionic gonadotropi
potency per vial. LIBELED: 1-21-58, S. Dist. N.Y.
*See also No. 5586.