1263. Misbranding of Special Compressed Tablets.    U. S. v. 96,000 Special Com
pressed Tablets.    Consent  decree  ordering the  release of the product
under bond.    (F. D. C. No. 10510.    Sample No. 48443-F.)
An agreement existed between the shipper and consignee of this product that
it was to be repackaged. When repackaged, however, the labeling contained
therapeutic claims that constituted misbranding.
. On August 31, 1943, the United States attorney for the Northern District
of Ohio filed a libel against 96,000 Special Compressed Tablets at Cleveland,
Ohio, alleging that the article had been shipped on or about June 9, 1943, by
Charles H. Dietz, Inc., St. Louis, Mo.
The article was labeled in part: "Special Compressed Tablet RX2742 Each
C. T. contains: Caffeine Alkaloid . . . ? gr. "Acetphenetidin . . . 2? grs. Aspi-
rin . . . 3? grs. Tinct. Gelsemium ... 2 Min." Examination showed that the
article had essentially the composition declared on its label.
The article was alleged to be misbranded (1) in that its labeling failed to
bear adequate directions for use; and (2) in that its labeling failed to warn
that frequent or continued use of an article containing acetophenetidin may
be dangerous, causing serious blood disturbances, and that not more than the
recommended doses should be taken.
On November 22,1943, the Jones Surgical Supply Co., Cleveland, Ohio, claimant,
filed an answer, alleging that the label which was used by it in repackaging the
product bore the required warnings, but admitting that the repackaged goods bore
words that the Government claimed did constitute misbranding. On the same
date the claimant having consented to the entry of a decree, judgment was
entered finding that the labels used by the claimant constituted misbranding,
and ordering that the product be released under bond, conditioned that it be
relabeled with labels approved by the Food and Drug Administration.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM
OFFICIAL OR OWN STANDARDS*