28442. Adulteration and misbranding of ampuls of sodium cacodylate; alleged 
adulteration and misbranding of ampuls of sodium iodide, sodium 
salicylate, caffeine sodlo-benzoate, glucose, magnesium sulphate, hex- 
amethylenamlne, sodium thiosulphate, emetine hydrochloride, sodium 
iodide and sodium salicylate, Migraitone, pituitary extract, glycero- 
phosphate compound, Iron, arsenic and phosphorus ampuls, iron caco- 
dylate; and alleged Misbranding of X-Bismercoil Compound and 
mercury blniodlde. U. S. v. Rovin Therapeutic Products, Inc. Plea of 
guilty to counts 1, 2, and 3. Fine, $500 on said counts. Remaining 
counts dismissed. (P. & D. No. 39496. Sample Nos. 12822-C, 12823-C, 
27904-C to 27908-C, incl., 27979-C to 27988-C, incl., 35101-C, 35103-C, 
35113-C, 35114-C, 35119-C.)
This information charged in counts 1, 2, and 3 the adulteration and mis- 
branding  of  sodium  cacodylate  ampuls  because  of a  deficiency  of  sodium
cacodylate and because of false and fraudulent curative and therapeutic 
claims in the labeling. It also charged in the remaining counts adulteration 
and misbranding of various pharmaceuticals because of variances from the 
declared ingredients and alleged false and fraudulent curative and therapeutic 
claims in the labeling of certain of the products.
On July 20, 1938, the United States attorney for the Eastern District of 
Michigan, acting upon a report by the Secretary of Agriculture, filed in the 
district court an information against Rovin Therapeutic Products, Inc., Detroit, 
Mich., alleging shipment by said company in violation of the Food and Drugs 
Act as amended, in the period from on or about May 4, 1935, to on or about 
December 3, 1936, from the State of Michigan into the States of Pennsylvania 
and Ohio of quantities of the above-listed pharmaceuticals, of which some 
were alleged to be adulterated and misbranded and the remainder were alleged 
to be misbranded in violation of the Food and Drugs Act as amended. The 
articles were labeled in part: "Rovin Laboratory, Detroit, Mich."
Count 1 alleged Adulteration of one lot of sodium cacodylate ampuls in that 
the article was sold under a name recognized in the National Formulary and 
differed from the standard of strength, quality, and purity as determined by 
the test laid down in the said formulary, since it yielded an amount of 
anhydrous sodium cacodylate corresponding to less than 69 percent, namely, 
not more than 20.3 percent of the amount listed on the label; whereas the 
formulary provides that ampuls of sodium cacodylate shall yield an amount of 
anhydrous sodium cacodylate corresponding to not less than 69 percent of 
the labeled amount, and the standard of strength, quality, and purity of the 
article was not declared on the container thereof. Further adulteration was 
alleged in said count in that the strength and purity of the article fell below 
the professed standard and quality under which it was sold, since each milliliter, 
or cubic centimeter, of the article was represented to contain 5 grains, or 0.324 
gram, of sodium cacodylate; whereas each milliliter, or cubic centimeter, con 
tained less than 0.324 gram, namely, not more than 0.066 gram ar-Tso^mm 
cacodylate equivalent to not more than 1.01 grains of sodium cacodylate per 
each milliliter, or cubic centimeter.
Count 2 alleged Misbranding of the said lot of sodium cacodylate in that 
the statements "1 Mil. (cc) Ampoules Sodium Cacodylate 5 grs. * * * Each 
Mil. (cc) contains: Sodium Cacodylate 0.324 gm. 5 grs.," borne on the boxes, 
and "1 Mil. (cc) Sodium Cacodylate 5 gr.," borne on the ampul label, were 
false and misleading since the ampuls contained less sodium cacodylate than 
so represented. Count 3 alleged that the said lot of sodium cacodylate was 
misbranded further in that certain statements, designs, and devices regarding 
Its therapeutic and curative effects, appearing on the labeling, falsely and 
fraudulently represented that it was effective as a therapeutic agent in condi- 
tions such as malaria, pellagra, anemia, neurasthenia, neuralgia, syphilis, and 
nonsyphilitic skin diseases; and effective as a general tonic and .to stimulate 
new blood formation. The remaining counts charged Adulteration of ampuls of 
sodium iodide, sodium salicylate, caffeine sodio-benzoate, sodium cacodylate, glu- 
cose, magnesium sulphate, hexamethylenamlne, sodium thiosulphate, and emetine 
hydrochloride in that they were sold under names recognized in the National 
Formulary but differed from the standard of strength, quality, and purity as 
determined by the tests laid down therein and also differed from their own 
declared standards; Adulteration of ampuls of sodium iodide and sodium 
salicylate, Migraitone, pituitary extract, glycerophosphate compound, iron, 
arsenic, and phosphorus ampuls, and ampuls of iron cacodylate in that they 
fell below their own professed standards; and misbranding of the said drugs 
because of failure to conform to their labeled strength; Misbranding of ampuls 
of X-Bismercoil in that It contained chlorobutanol, a derivative of chloroform, 
and its label failed to bear a statement of the quantity of chlorobutanol con- 
tained in the article; Misbranding of ampuls of mercury biniodide in that the 
article contained mercury biniodide in excess of the amount declared on the 
label; and misbranding of ampuls of sodium iodide, sodium salicylate, X-Bis- 
mercoil, caffeine sodio-benzoate, sodium salicylate, magnesium sulphate, 
hexamethylenamlne, emetine hydrochloride, sodium iodide, and sodium 
salicylate, glycerophosphate compound, ampuls of iron, arsenic, and phosphorus, 
and iron cacodylate ampuls in that certain statements in the labeling falsely 
and fraudulently represented the curative and therapeutic effectiveness of the 
articles.
On July 27, 1938, the defendant entered a plea of guilty to counts 1, 2, and 3, 
and the court imposed a fine of $200 on the first count, $200 on the second, 
and $100 on the third.   The remaining counts were dismissed by the court.
HAEET L. BROWN, Acting Secretary of Agriculture.