2204. Adulteration Betbiamin, Livitamin, and calcium gluconate.    U. S. v. The
S. E. Massengill Company.    Plea of guilty.    Fine, $3,000.     (F. D. C. No.
20204.    Sample Nos. 7678-H, 20850-H, 21738-H, 21757-H.)
INFORMATION FILED : February 3, 1947, Eastern District of Tennessee, against
The S. E, Massengill Co., a corporation, Bristol, Tenn.
ALLEGED SHIPMENT: On or about December 15, 1944, and November 1 and De-
cember 8,1945, from the State of Tennessee into the States of Missouri and New
York.
LABEL, IN PART : "Bethiamin A Brand of Thiamine Hydrochloride (Bi) * * *
For Intramuscular or Intravenous Administration," "Calcium Gluconate,
10?," or "Livitamin Represents in one Fluid Ounce * * * Thiamine Hydro-
chloride (BO    3 mg. in 100 cc.   10.14."
NATURE OF CHARGE: Bethiamin. Adulteration, Section 501 (a) (1), the article
consisted in part of a filthy substance by reason of the presence of viable mold;
and. Section 501 (c), the purity and quality of the article fell below that which
it purported and was represented to possess, in that it purported and was rep-
resented to be suitable and appropriate for intramuscular and intravenous ad-
ministration, a use which requires a sterile product, whereas the article wa's un-
suitable and inappropriate for intramuscular and intravenous administration
since it was unsterile by reason of contamination with viable mold.
Calcium gluconate. Adulteration, Section 501 (d), boric acid had been sub-
stituted in part for "Calcium Gluconate Ampuls," in that the article purported
to be and was represented as "Calcium Gluconate Ampuls," a drug the name of
which is recognized in the United States Pharmacopoeia, an official compendium,
and the article contained boric acid, whereas "Calcium Gluconate Ampuls," the
specifications of which are set forth in the Pharmacopoeia, do not contain boric
acid.
Livitamin. Adulteration, Section 501 (c), the strength of the article differed
from that which it was represented to possess, in that it was represented to
contain 3 milligrams of thiamine hydrochloride in 1 fluid ounce and 10.14 milli-
grams of thiamine hydrochloride in 100 cc, whereas it contained less thiamine
hydrochloride than represented.
DISPOSITION : March 4, 1047. A plea of guilty having been entered, the court
imposed a fine of $1,000 on each of the 3 counts of the information.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM
OFFICIAL OR OWN STANDARDS*