2952. Misbranding of Orange Blossom Suppositories.   U. S. v. 35 Packages
*    *    *.    (F. D. C. No. 27999.   Sample No. 57010-K.)
LIBEL FILED :    September 27,1949, Southern District of New York.
ALLEGED SHIPMENT : On or about August 24, 1949, by the Dr. J. A. McGill Co.,
from Chicago, 111.
PRODUCT : 35 packages each containing 6 Orange Blossom Suppositories at New
York, N. Y. Examination showed that the suppositories consisted essentially
of ammonium alum, approximately 50 percent, borax and siliceous material
in a fatty base.
NATURE OF CHARGE : Misbranding, Section 502 (j), the article was dangerous to
health when used in the dosage and with the frequency and duration prescribed,
recommended, and suggested in its labeling, namely, "Directions Remove
tinfoil and at bedtime insert one suppository in vagina and with your finger
push it up as far as you can. Let it remain there undisturbed for three days.
Then at night take a douche of warm water, and on the evening of the second
day apply again as above, making the application every five days excepting at
monthly periods, allowing four days for the periods, then apply the suppository
every five days. The use of Orange Blossom Suppositories is not recommended
at the menstrual period or during pregnancy."
DISPOSITION: January 16, 1950. Default decree of condemnation. The court
ordered that a number of the suppositories be released to the Food and Drug
Administration and that the remainder be destroyed.
DRUGS  ACTIONABLE  BECAUSE  OF FAILURE TO  BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS