5010. Digitalis tablets.    (F. D. C. No. 38974.    S. No. 42-339 M.)
QUANTITY: 1 fiber drum of 11,425 tablets and 2 fiber drums, each containing. 
65,000 tablets, at Denver, Colo.
SHIPPED :   2-22-55, from New York, N. Y.
RESULTS or INVESTIGATION : The tablets were manufactured by the consignee 
from powdered digitalis leaves, which had been shipped in bulk from New 
York,N.Y.
Analysis showed that the digitalis potency of the article was less than 85 
percent of its declared potency of 1% grains of U. S. P. digitalis per tablet. 
The United States Pharmacopeia provides that the potency of digitalis, cal- 
culated from the prescribed assay preparation, is satisfactory if the result 
is not less than 85 percent and not more than 120 percent of the labeled 
potency.
LIBELED :   3-7-56, Dist. Colo.; libel amended 3-15-56.
CHARGE: 501 (b)-the strength of the article while held for sale differed from 
the standard set forth in the United States Pharmacopeia for digitalis tablets; 
and 502 (a)-the label statement "Each Tablet Contains: Digitalis. U. S. P. 
lYz gr-" was false and misleading as applied to an article which con- 
tained less than 1% grains of U. S. P. digitalis per tablet.
DISPOSITION :    5-9-56.   Default-destruction.