30996. Adulteration  and misbranding of  Causalin.     U.   S.  v.  Amfre Drug;  Co.,
Inc., and Lewis Stern. Pleas of guilty. Fines, $420. (F. & D. No. 42678. 
Sample Nos. 25962-D, 25963-D, 25964-D, 30071-D to 30074-D, incl., 30092-D 
to  30097-D,  incl.,  35452-D,  35453-D,  35567-D,  35569-D,  35570-D,  41997-D.)
This product was represented to contain aminopyrine and quinolinesulfonate, 
whereas it contained in addition to such drugs a material proportion of 
salicylic ethyl ester  carbonate.
On January 30, 1940, the United States attorney for the Southern District of 
New York, acting upon a report by the Secretary of Agriculture, filed in the
district court are information against the Amfre Drug Co., Inc., New York, 
N. Y., and Lewis Stern, president of the corporation, alleging shipment in vio- 
lation of the Food and Drugs Act, within the period from on or about July 1 
to on or about December 27, 1938, from the State of New York into the States 
of New Jersey, Pennsylvania, Massachusetts, and Rhode Island, of quantities 
of Causalin which was adulterated and misbranded. The boxes containing a por- 
tion of the article were labeled in part: "Aminodimethylpyrazolon-quinolinesul- 
phonate." A circular and a leaflet accompanying one of the shipments bore 
the    statements:   (Circular)     "Amino-dimethyl-pyrazolon-quinoline-sulphonate
* * * The -drug used in this study is supplied by Amfre Drug Company 
under the name of Causalin"; (leaflet) "Amino-dimethyl-pyrazolon-quinoline- 
sulphonate  (Causalin)."
The article was alleged to be adulterated in that its purity fell below the 
professed standard under which it was sold in that it was represented to 
consist of aminopyrine (dimethylaminophenyldimethylpyrazolon) and quino- 
Unesulfonate, namely, aminopyrine and quinoUnesulfonate; whereas it con- 
tained in addition to said drugs a material -proportion of salicylic ethyl ester 
carbonate.
It was alleged to be misbranded in that it consisted of a mixture of amino- 
pyrine (dimethylaminophenyldimethylpyrazolon), salicylic ethyl ester carbon- 
ate, and quinoUnesulfonate and was offered for sale under the name of another 
article. "Aminodimethylpyrazolon-QuinoUnesulphonate," i. e., aminopyrine and 
quinoUnesulfonate.
Portions of the article were alleged to be misbranded further in that the 
statements, (boxes of portion) "Aminodimethylpyrazolon-Quinolinesulphonate," 
and (circular accompanying one shipment) "Chemotherapy: Amino-dimethyl- 
pyrazolon-quinoline-sulphonate * * * The drug used in this study is sup- 
plied by Amfre Drug Company of New York City under the name of Causalin
* * * Kimble reports fifty-six cases of chronic nonspecific arthritis were 
treated with amino-dimethyl-pyrazolon-quinoline-sulphonate (Causalin)," were 
false and misleading in that the said statements represented that the article 
consisted of aminopyrine and quinoUnesulfonate; whereas it consisted of 
aminopyrine, salicylic ethyl ester carbonate, and qiiinolinesulfonate.
The information alleged that the article was also misbranded in violation 
of the Federal Food, Drug, and Cosmetic Act, as reported in notice of judgment 
No. 76 published under that act.
On January 30, 1940, the defendants entered pleas of guilty and the court 
imposed fines for violation of both acts. The fines imposed on the counts 
charging violation of the Food and Drugs Act amounted to $210 against each 
defendant.
GROVER B. HUX, Acting Secretary of Agriculture.