5409. Digitoxin powder and digitoxin tablets.    (F. D. G. No. 40117.   S. Nos.
42-964/5 M.)
QUANTITY:   1   24-gram Ml., 14   1,000-tablet btls., and 4   100-tablet btls. at
Peoria, 111.
SHIPPED :   Between 12-1-55 and 1-18-57, from Newark, N. J., by Ohemo Puro
Mfg. Corp.
LABEL IN PAET: (Btl.) "Digitoxin U. S. P. * * * For Manufacturing, Process-
ing or Repacking" and "Digitoxin Tablets Each tablet contains Digi-
toxin. . . . 0.22mg. (1/300gr.)."
RESULTS OF INVESTIGATION : The above tablets were prepared by the consignee
from the bulk powder shipped on or about 12-1-55.
Examination showed that the powder contained not more than 85.8 percent
of digitoxin and that the tablets contained not more than 70.2 percent of
digitoxin when assayed by the methods specified in the United States Pharma-
copeia. The Pharmacopeia requires that the assay result be not less than 90
percent of digitoxin.
LIBELED :    4-4-57, S. Dist, 111.
CHARGE: 501 (b)-the article, when shipped and while held for sale, purported
to be a drug, "Digitoxin," the name of which is recognized in the United States
Pharmacopeia, an official compendium, and the strength of the article differed
from, and its quality fell below, the standard set forth in such compendium.
DISPOSITION :   5-13-57.   Default-destruction.