4314. Misbranding of rubber diaphragms.   U. S. v. 166 Devices * * *.   (F. D. C.
No. 35680.   Sample No-55178-L.)
LIBEL FILED :   October 1,1953, Eastern District of Wisconsin.
ALLEGED SHIPMENT: On or about August 25, 1953, by Hychex Products, from
Chicago, IU.
PRODUCT : 166 devices, consisting of rubier diaphragms, contraceptive type, each
of which was contained in a cardboard box, at Milwaukee, Wis.
RESULTS OP INVESTIGATION : The device was a prescription device, and its label
did not bear the legend "Caution Federal Law Restricts This Device To
Sale By or On The Order of a Physician." Further, the device was not
restricted by the dealer to sale by or on the order of a physician.
LABEL, IN PAST:    (BOX Cover)    "PreCare   Mensinga Diaphragm."
NATURE OF CHARGE: Misbranding, Section 502 (f) (1), the labeling of the
device failed to bear adequate directions for use.
DISPOSITION : January 27, 1954. Default decree of condemnation and destruc-
tion.
DRUGS ACTIONABLE BECAUSE OF DEVIATION FROM OFFICIAL OR
OWN STANDARDS