2552. Misbranding of penicillin-G sodium crystalline.   U. S. v. 88 Vials   *   *   *.
, (F. D. C. No. 25508.    Sample No. 9439-K.)
LIBEL FILED :    September 1,1948, Southern District of New York.
ALLEGED SHIPMENT: On or about March 8, 1948, from Newark, N. J., by the
Vitamin Corporation of America.
PRODUCT :   88   100,000-unit vials of penicillin-G sodium crystalline at New York,
NY.
LABEL, IN PART: "Penicillin-G Sodium Crystalline * * * Manufactured for
Solvecillin, Inc.   *    *   *   Newark, New Jersey."
NATURE OF CHARGE: Misbranding, Section 502 (1), the article was represented
as a drug composed wholly of penicillin-G sodium crystalline, a derivative of
a kind of penicillin, and it was not from a batch with respect to which a
certificate or release had been issued as provided for by Section 507; and,
Section 502 (a), the label statement "Lot No. 3127C Exp. Date Nov. 1950" was
false and misleading since the statement represented and suggested that the
article had been certified by the Federal Security Administrator under such
identifying terms, whereas, it had not been so certified.
DISPOSITION: September 23, 1948. Default decree of condemnation. The
product was ordered delivered to a charitable organization.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAIL-
URE TO BEAR ADEQUATE DIRECTIONS OR WARNING
STATEMENTS*
2553.?Action to enjoin and restrain the interstate shipment of Paracelsus.   U. S.
v. American Biochemical Corporation.   Injunction granted.    (Inj. No.
203.)
COMPLAINT FILED :   On or about November 18, 1948, Northern District of Ohio,
against the American Biochemical Corp., Cleveland, Ohio.
ALLEGED VIOLATION : The complaint alleged that the defendant had been and was
continuing to ship in interstate commerce a product known as Paracelsus,
which consisted essentially of a mixture of chemical salts and which was
distributed for use both as a dietary food supplement and for therapeutic
purposes.
That accompanying the product there was and had been theretofore printed
and graphic matter relating to the product entitled "Malnutrition, Disease,
Due to Mineral Lack," which described the product and related to it; that the
printed and graphic matter had been shipped by the defendant into inter-
state commerce and had been used with the product by the consignees and
had been associated together with the product.
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in the
accompanying labeling were false and misleading. These statements repre-
sented and suggested that the article was effective to prevent and cure malnu-
trition and disease, to provide pep, to stimulate hormone production, and to
prevent and cure arthritis; and that all individuals suffer from mineral de-
ficiency and would benefit by use of the article. The article was not effective
for such purposes and was not capable of fulfilling the promises of benefit
?See also No. 2596.
stated and implied. Further misbranding, Section 502 (a), the following label
statements were false and misleading since if taken as directed, the article
would supply materially less calcium and iron than stated:
When Taken According to Directions Will Supply Percentage of Daily
Requirements as Listed
Calcium
Iron
Man
13.50??16.00
Woman
13.50??16.00
Pregnancy latter half
   7.00??12.75
Lactation
    5.25??12. 75
Children 1 to 9 years
10. 75??19.20
Children 10 to 12 years
   9.00??16.00
Girls 13 to 15 years
   8.00??13. 00
Boys 12 to 15 years
   7. 50??13. 00
Girls 16 to 20 years
10. 50??13. 00
Boys 16 to 20 years
   7.50??13. 00
Further misbranding, Section 502 (f) (1), the article failed to bear ade-
quate directions for use since at times it failed to bear labeling which set
forth the purposes for which the article was intended to be used as a drug.
The article was alleged also to be adulterated and misbranded under the
provisions of the law applicable to foods, as reported in notices of judgment
on foods.
PBAYEB OF COMPLAINT : That the defendant be restrained and enjoined during
the pendency of the action and permanently, from shipping in interstate
commerce an article known as Paracelsus, or under any other name, which
was adulterated or misbranded as alleged.
DISPOSITION : December 10,1948. The defendant having consented to the entry
of a decree, a permanent injunction was granted enjoining and restraining
the defendant from shipping in interstate commerce an article under the trade
name Paracelsus, or under any other name, which was adulterated or mis-
branded as alleged in the complaint.