LIBELED: 5-17-62, W. Dist. Okla.

CHARGE: 502 (a)-when shipped and while held for sale, (Oscilloclast) the labeling accompanying the device contained false and misleading representa tions that the article was adequate and effective as a treatment for overcoming acidosis, bubonic plague, diabetes, malaria, polio, radium burn, tuberculosis warts, and (Pathoclast) the labeling accompanying the device contained fals and misleading representations that the article was adequate and effectiv as a treatment for overcoming diseases of the kidneys, lungs, nerves, hear liver, pituitary, spleen, and other organs; and 502(f)(1)—(Oscilloclast ari Pathoclast) when shipped and while held for sale, and (Pedasine) while hell for sale, the labeling failed to bear adequate directions for use and the artic were not exempt from that requirement since the devices were not safe for use except under the supervision of a practitioner licensed by law to direct the use of such devices, and the labeling failed to bear the statement "Caution Federal law restricts this device to sale by or on the order of a physician" and the devices were not in the possession of a person who was regularly and lawfully engaged in the distribution of prescription devices and were not in the possession of a practitioner licensed in the State of Oklahoma to use, or order the use of, such devices.

DISPOSITION: 6-20-62. Default-delivered to the Food and Drug Administra tion.

7087. Electro Sine Galvanic device. (F.D.C. No. 45815. S. No. 67-356 R.) QUANTITY: 1 device at Dallas, Tex.

SHIPPED: 10-12-59, from Tiffin, Ohio, by L. L. Roby Manufacturing Corp. LABEL IN PART: (Front) "Electro Sine Galvanic Model 200" and (back) “Marufactured by L. L. Roby Manufacturing Corp., Tiffin, Ohio."

RESULTS OF INVESTIGATION: The device was a small suit-case-type container housing an electronic circuit for the production of various forms of electrica. current. The control panel contained a switch, pilot lights, a 0-25 DC ma ne ter, and an array of knobs for the selection and adjustment of the current type intensity, and frequency. This panel also had three female outlet plus to which the applicators were attached and one plug labeled "foot switch The device produced surged, pulsating, or continuous faradic pulses and a galvanic current. Included were two sets of electrodes, cloth pads 1% inches in diameter, and two metal strips.

LIBELED: 6-19-61, N. Dist. Tex. ; amended libel 9-8-61.

CHARGE: 502(f) (1)—when shipped and while held for sale, the labeling falei to bear adequate directions for use.

DISPOSITION: 4-23-62. Consent decree provides that device may be take down under bond by claimant, L. L. Roby Manufacturing Corp., to be bronct into compliance with the law.

7088. Lindquist Chronosonic Ultrasound device. (F.D.C. No. 47387. S. Nis 83-361/2 P.)

QUANTITY: 2 devices at Welch, Okla.

SHIPPED: 4-9-56 and 6-27-57, from Los Angeles, Calif., by R. J. Lindquist Co. LABEL IN PART: (Front of device) "Lindquist Chronosonic Ultrasound R J Lindquist Co. 2419 W. 9th Street Los Angeles 6, Calif. ・・・ Model 401 Serial 7150 [or “7384”].”

ACCOMPANYING LABELING: "Bare Drugless Arthritis Cure" reprint from Los Angeles Herald Examiner, Friday, July 16, 1954; "Prolapse of Intervertebral Discs" reprint from The British Journal, May 1952; "The Myofascial Genesis of Pain" reprint from May 1952 Postgraduate Medicine, Vol. 11, No. 5; "What a Therapist May Expect From Ultrasound" by Frank Stephen Zach, M.D.; "Therapeutic Application of Ultrasound Energy" reprint from the Journal of the Florida Medical Assoc. 43: 341-346 (Oct.) 1956; "Ultrasonic Therapy: A Review of its Present Status and Future Possibilities" by Kenneth Phillips, M.D. C.A.C.P., Miami, Florida; "Ultrasonics in Biology and Medicine" English language edition of Ultraschall in Medizin und Grenzgebieten, Vol. 1, No. 1, 1956; "Silent Sound" leaflet reprint from "Parade," May 13, 1956; "The Application of Ultrasound in Physical Medicine" by E. F. Carter, Sr., Director, Dept. of Physical Med., Tampa Municipal Hospital; "Use of Sound to Treat Disease to be Demonstrated to Medics" reprint from The Miami Herald, Sunday, Nov. 9, 1952, by Bert Collier; "Treatment With Ultra-sound Waves" by E. F. Carter, M.D., Head of Dept. of Physical Med., Tampa Municipal Hospital, Tampa, Florida; "Use of Ultrasonation in an Orthopedic Practice" by Harry Alban, M.D. F.A.S.C., Long Beach, California; "Ultrasonics and Therapy" reprint from page 46 of Radio-Electronics for November 1951; "Ultrasonic Therapy" reprint from The Physical Therapy Review, Vol. 34, No. 11, November 1954; "Ulcers Are Cured-Sound Waves Used for The Relief of Pain" reprint from page 8-A, Miami Daily News, Sunday, November 9, 1952; "A Few Cases Treated With Ultrasound" leaflet by Dr. E. F. Carter, M.D.; "Lindquist Chronosonic Ultrasound Generator Portable Model No. 401 with Model 90 Soundhead" descriptive leaflet by R. J. Lindquist Co.; "Technical Application of Ultrasound in Therapy (& insert) Spinal Levels of Referred Inner Organs" instructions for use of Chronosonic Ultrasound Model 401 in treating areas of the human body; "Ultrasound Therapy" by Miller & Weaver, reprinted from The Physical Therapy Review, Vol. 34, No. 11, November 1954. RESULTS OF INVESTIGATION: The article was an electronic high-frequency oscillator circuit of the self-rectifying type, having a pulsed power output and a soundhead applicator which generated the ultrasound energy. The circuit was enclosed in a simulated leather case with storage space for the electrical wires and soundhead. The gray "hammertone" panel contained a milliampere meter, internal timer with automatic shutoff, tuning control, and a 10-position power control. The soundhead was connected to the instrument circuit through a flexible coaxial cable.

CHARGE: 502(a)-when shipped, the accompanying labeling of the article contained false and misleading representations that the article was an adequate and effective treatment for arthritis, bursitis, arteriosclerosis, and other crippling and killing diseases; and 502(f) (1)—the labeling of the article failed to bear adequate directions for use.

DISPOSITION: 9-14-62. Default-the devices were ordered to be delivered to the Food and Drug Administration; the accompanying labeling was destroyed. 7089. Neurolinometer device. (F.D.C. No. 47715. S. No 70-894 T.)

QUANTITY: One device at Hamlin, Tex.

SHIPPED: During November 1955, from Cumberland, Wis., by William A. Patillo, D. C.

RESULTS OF INVESTIGATION: Examination indicated that the device was housed in a black, suitcase-type container, about 15 inches long, 94 inches wide, and 51⁄2 inches deep. The face of the device contained 8 knobs variously labeled in part "ten" "one" "cervical" or "base." The device otherwise consisted of

a monopolar electrode, a single-stage amplifier, and a power supply unit, the output of which was applied to a section of wire mesh attached beneath a sheet of bakelite.

LIBELED: 8-8-62, N. Dist. Tex.

CHARGE: 502(a)—when shipped and while held for sale, the label statement "This instrument has no known analytical or therapeutic value," was misleading as applied to a product which was intended for use in the diagnosis of disease in the course of the professional practice of a practitioner in chiropractic; 502(b) (1)—the label failed to bear the name of the manufacturer, packer, or distributor; and 502(f) (1)—the labeling of the article failed to bear adequate directions for use for the purpose for which it was intended, namely, the diagnosis of disease in man, in that the article was worthless for use for such purpose and adequate directions could not be given for the use of the article for such purpose.

DISPOSITION: 9-26-62. Default-destruction.

DRUG FOR VETERINARY USE

7090. Dr. Mayfield's Turkey Prescription. (F.D.C. No. 46155. S. No. 54-596 R.) QUANTITY: 1 keg containing 16 unlabeled 5-lb. bags at Lone Rock, Wis. SHIPPED: 4-24-61, from Charles City, Iowa, by Dr. Mayfield Laboratories. LABEL IN PART: (Keg) "Dr. Mayfield Turkey Prescription Net Weight 20-5 pounds *** Active ingredients: Sodium Arsanilate, each ounce contains 94 grains arsenic expressed as arsenic trioxide * * manufactured by Dr. Mayfield Laboratories, Charles City, Iowa."

RESULTS OF INVESTIGATION: Analysis showed the product to be a pinkish-white. finely ground powder containing essentially the amount of arsenic trioxide declared on its label.

LIBELED: 8-2-61, W. Dist. Wis.

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 quan tity of contents; 502 (e) (2)-its label failed to bear the common or usual name of each active ingredient; 502(f) (1)—the labeling failed to bear adequate directions for use.

DISPOSITION: 4-25-62. Consent-claimed by Lone Rock Milling Co., Lone Rock Wis., and released under bond to be relabeled.

DRUGS ACTIONABLE BECAUSE OF CONTAMINATION WITH FILTH 7091. Various medicines and antibiotic drugs. (F.D.C. No. 44993. S. N1 35-990 R.)

QUANTITY: 7 ctns., containing a total of 542 lbs., at Brooklyn, N.Y.

SHIPPED: The articles were delivered, on 9-6-60, to a ship pier at Brooklyn, NY. for shipment to Reykjavik, Iceland.

See also No. 7068.

RESULTS OF INVESTIGATION: Examination showed that the articles were submerged in polluted river water. The contamination occurred as a result of a storm on 9-13-60, which flooded the pier where the articles were stored. LIBELED: 10-13-60, E. Dist. N.Y.

CHARGE: 501 (a) (2)—while in interstate commerce, the articles were held under insanitary conditions.

DISPOSITION: 3-17-61. Consent-claimed by Stefan Thorarensen, Ltd., and released for reconditioning. The articles proved to be unfit for use and were destroyed.

DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM OFFICIAL OR OWN STANDARDS

DRUGS AND DEVICES FOR HUMAN USE

7092. Imitation Diuril tablets. (F.D.C. No. 45557. S. Nos. 7-596 R, 53-481 R.) INFORMATION FILED: 3-14-61, Dist. Mass., against Saul Bogdanov, t/a Victory Pharmacal Co., Roxbury, Mass.

ALLEGED VIOLATION: Prior to 7-11-60, the defendant caused a quantity of chlorathiazide tablets to be offered for sale and sold as Diuril tablets which act resulted in the tablets being misbranded.

CHARGE: 501 (d) (2)—imitation Diuril tablets had been substituted for Diuril tablets; 502 (i) (2)—the article was an imitation of another drug, Diuril; and 502 (i) (3)—the article was offered for sale under the name of another drug, Diuril.

PLEA: Not guilty.

DISPOSITION: On 6-5-61, the case came to trial before the court and jury. On 6-7-61, the jury returned a verdict of not guilty.

7093. Tri-Tabs. (F.D.C. No. 46600. S. Nos. 17-989/90 R, 17-993 R.) QUANTITY: 14 5,000-tablet ctns., 23 1,000-tablet btls., 2

500-tablet btls., and 34,000 tablets in unlabeled strip-paks of Tri-Tabs Purple; 5 5,000-tablet ctns., 6 1,000-tablet btls., and 9,000 tablets in unlabeled strip-paks of Tri-Tabs Yellow; and 10 5,000-tablet ctns., 24 1,000-tablet btls., 2 500-tablet btls., and 32,000 tablets in unlabeled strip-paks of Tri-Tabs Pink, at Denver, Colo., in possession of Western Research Laboratories.

SHIPPED: On 8-28-58 and 2-17-61, from St. Louis, Mo., by Keith Victor Pharmacal Co.

LABEL IN PART: (Btl. and ctn.) "Tablets TRI-TABS PURPLE (TPT) Each Tab Contains: (Dextro Amphetamine Hydrochloride) 15 mg. Manufactured by Western Research Laboratories Denver, Colorado" and "Tablets TRI-TABS YELLOW (TTY) [or "TRI-TABS PINK (TTP)"] One-A-Day Divided Dose Tablets Each Tablet Contains: (Dextro Amphetamine Hydrochloride) 15 mg. *** AVERAGE DOSE: Adults, 1 tablet on arising (provides relatively the same therapeutic effect for one-third the total dose taken t.i.d.) * ** Manufactured by Western Research Laboratories Denver, Colorado."

RESULTS OF INVESTIGATION: The articles were shipped in bulk and repacked by the dealer as described above. Analysis of the articles showed that Tri-Tabs Purple contained from 65 to 124 percent of the declared amount of dextroamphetamine hydrochloride which was released in a uniform manner over a period of 7 hours; Tri-Tabs Yellow contained from 76 to 131 percent of the

declared amount of dextro-amphetamine hydrochloride which was released completely within 1 hour; and Tri-Tabs Pink contained from 74 to 137 percent of the declared amount of dextro-amphetamine hydrochloride which was released in a uniform manner over a period of 7 hours or of which about 50 percent was released in 2 hours.

LIBELED:

10-30-61, Dist. Colo.; amended libel 3-19-62.

CHARGE: 501(c)—when shipped and while held for sale, the strength of the articles differed from that which they purported and were represented to possess, namely, 15 milligrams of dextro-amphetamine hydrochloride in each tablet, since the dextro-amphetamine hydrochloride content of the tablets ranged from 9.70 to 13.34 milligrams per tablet, and from 17.35 to 20.62 milligrams per tablet; and 502 (a)-when shipped and while held for sale, the label statement "Each Tablet Contains: (Dextro Amphetamine Hydrochloride) 15 mg." was false and misleading since each tablet does not contain 15 mgs. of dextro-amphetamine hydrochloride; and (Tri-Tabs Yellow and TriTabs Pink) when shipped and while held for sale, the label statement "OneA-Day Dividend Dose Tablets *** provides relatively the same therapeutic effect of one-third the total dose taken t.i.d. (three times daily)" was false and misleading since the articles did not provide the same therapeutic effect as onethird the total dose taken three times daily. DISPOSITION: 4-19-62; amended decree 4-30-62.

7094. Span-RD time disintegrating capsules.

007/8 T.)

Default-destruction.

(F.D.C. No. 46792. S. Nos. 18

QUANTITY: 1 40,300-capsule drum, 10 1,000-capsule btls., 33 500-capsule btls. and 58 cases, 11 100-capsule btls. each of Span-RD; and 1 82,900-capsule drum, 12 500-capsule btls., and 20 cases, 12 50-capsule btls. each, of Span-RD 12, at Houston, Tex.

SHIPPED: Between 5-16-61 and 6-14-61, from Hoboken, N.J., by Kingston Laboratories, Ltd.

Usta'

LABEL IN PART: (Btl.) "Span-RD (Ratiodrine Sustained Release Capsules) Each Time Disintegrating Capsule Contains: d-Methamphetamine HCl 12 mg dl-Methamphetamine HCl 6 mg. Butabarbital 30 mg. Warning: • Caution *** Average Dose: * Metro Med. Inc. Houston, Texas" and "Span-RD 12 (Ratiodrine Sustained Release Capsule) Each Time Disintegrating Capsule Contains: d-Methamphetamine HCl 8 mgs. dl-Methamphetamine HCl 4 mgs. Butabarbital 30 mgs. Warning * • Caution Dose *** Metro Med. Inc. Houston, Texas." RESULTS OF INVESTIGATION: Analysis showed that the articles contained (Span RD) approximately 78 percent of the declared amount of butabarbital sodizz and approximately 87 percent of the declared amount of methamphetamine hydrochloride; and (Span-RD 12) approximately 74 percent of the declared amount of butabarbital sodium and approximately 79 percent of the declared amount of methamphetamine hydrochloride; and that the capsules (both lots would disintegrate completely in simulated gastric fluid in approximately tw hours.

The articles in the bottles were repacked from the bulk drums after shipment.

LIBELED: 12-22-61, S. Dist. Tex.

CHARGE: 501 (c)-when shipped, the strength of the articles differed from and their quality fell below, that which they purported to possess, since the