30013. Adulteration and misbranding of Biural Fitch.    U. S. v. 25 Packages of
Biural Fitch.   Default decree of condemnation and destruction.    (F. & D.
No. 44179.    Sample No. 34304-D.)
This product was labeled to indicate that it was a solution of phenobarbital 
sodium suitable for parenteral administration; whereas it contained suspended 
crystalline material rendering it unsuitable for such purpose.
On October 17, 1938, the United States attorney for the District of Columbia, 
acting upon a report by the Secretary of Agriculture, filed in the district court 
a libel praying seizure and condemnation of 25 packages of Biural Fitch at 
Washington, D. C.; alleging that the article had been shipped in interstate com- 
merce on or about July 19,1938, by William A. Fitch, Inc., from New York, N. Y.; 
and charging adulteration and misbranding in violation of the Food and Drugs 
Act.
The article was alleged to be adulterated in that its purity fell below the 
professed standard or quality under which it was sold, namely, (carton) "Air.pills 
* * * Each cc represents phenobarbital sodium 0.13 Gm. (2 grs.)," which 
created the impression that the article contained a solution of phenobarbital 
sodium suitable for parenteral administration; whereas it contained a consider- 
able proportion of suspended crystalline matter rendering it unsuitable for such 
purpose.
Misbranding was alleged in that the statements on the carton and ampul, 
"Each 2cc represents phenobarbital sodium 0.13 gm. (2 grs.)," was false and 
misleading when applied to a preparation which was not a clear solution but 
contained a material amount of suspended crystalline material. It was alleged 
to be misbranded further in that it was offered for sale under the name of 
another article, namely, "Ampuls * * * Phenobarbital sodium 0.13 Gm. (2 grs.) 
Stabilized," that is, a solution of phenobarbital sodium suitable for parenteral 
administration.
On December 15,1938, no claimant having appeared, judgment of condemnation 
was entered and the product was ordered destroyed.
HARRY It. BROWN, Acting Secretary of Agriculture.