4230. Action to enjoin and restrain interstate shipment of drugs intended for
injection. U. S. v. Milton A. Calesnick (Addison Laboratories). Tempo-
rary restraining order entered; order subsequently vacated and dis-
missed.   (Inj. No. 253.)
COMPLAINT FILED : August 14, 1952, Eastern District of Pennsylvania, against
Milton A. Calesnick, trading as Addison Laboratories, Philadelphia, Pa.
NATURE OF CHARGE : The complaint alleged that the defendant was engaged
in manufacturing and distributing and shipping in interstate commerce various
drugs intended for injection into the human body which were adulterated and
misbranded as follows:
(a)?Adulteration, Section 501 (b), a number of the drugs purported to be
-and were represented as drugs, the names of which are recognized in official
compendia, namely, the United States Pharmacopeia and the National Formu-
lary, and the strength of the drugs differed from, and their quality and purity
fell below, the standards set forth in such compendia; Section 501 (c), in the
case, of a number of the drugs, their strength differed from, and their purity
and-quality fell below, that which they purported and were represented to
possess; and, Section 501 (d) (2), in the case of a number of the drugs,
certain substances had been substituted for the drugs.
(b)?Misbranding, Section 502 (a), the labeling of a number of the drugs
bore false and misleading statements with respect to the nature and quantity
of the ingredients contained in the drugs.
The complaint alleged further that the adulterated and misbranded condi-
tion of the drugs resulted from deficiencies in the ingredients of the drugs,
the presence of ingredients in amounts in excess of those declared on the
labels or required by the standards set forth in the official compendia, the
substitution of other drugs for the drugs involved, and the presence of viable
micro-organisms evidencing an unsterile product. For example, examination
of samples from interstate shipments made by the defendant of certain articles
of drug for injection, to wit, liver-folic acid-Bus, aminophylline, sodium sali-
cylate and iodide with colchicine, and Lynntestro, disclosed that the liver-
folic acid-Bu contained approximately 7 percent of the declared amount of
vitamin Bu; that the aminophylline contained theophylline in excess of the
amount permitted by the United States Pharmacopeia; that a number of ampuls
of the sodium salicylate and iodide with colchicine did not contain the de-
clared ingredients in that aminophylline had been substituted for such ingredi-
ents; and that the Lynntestro was not sterile since it contained viable
micro-organisms.
The complaint further alleged that the defendant was well aware that his
activities were violative of the Act. Inspections were made of the defendant's
plant at Philadelphia, Pa., by inspectors of the Food and Drug Administration
on May 18 and August 2, 1950, April 19 and November 26, 1951, and June 9,
20,*a.n$k23, and July 22, 1952, at which times the defendant was informed of
the lack of analytical and sterility controls in the manufacture of drugs and
of the confusion and disorder existing in the plant, which would result in
errors pf composition and labeling, and was warned that such conditions also
would result in the drugs being adulterated and misbranded as aforesaid..
*SecaJ,e<KKo. 4225.
318014-5*--*
defendant by the plant inspections, the defendant continued to introduce and
deliver for introduction into interstate commerce drugs which were adulterated
and misbranded as described above.
DISPOSITION: On August 14, 1952, the court entered a temporary restraining
order, under which the defendant was temporarily restrained and enjoined
from directly or indirectly introducing, or delivering for introduction into
interstate commerce, drugs adulterated and misbranded in the manner com-
plained of. On August 20,1952, pursuant to a stipulation between the Govern-
ment and the defendant, the court entered an order continuing the temporary
restraining order in effect.
On December 21, 1953, upon consideration of a motion from the defendant
showing that the drugs being shipped by. the defendant were in compliance
with the law in that such drugs were being manufactured under proper
analytical and sterility controls, the court entered an order vacating the
temporary restraining order and dismissing the complaint.