3628. Adulteration of phenobarbital tablets.   U. S. v. 4 Bottles, etc.   (F. D. C.
No. 31399.   Sample Nos. 25563-L,25565-L.)
LIBEL FILED :    July 27, 1951, Eastern District of Pennsylvania.
ALLEGED SHIPMENT : On or about May 25, 1951, by the Robin Pharmacal Corp.,
from New York, N. Y.
PRODUCT : Phenobarbital tablets. 4 25,000-tablet bottles, 12 1,000-tablet bot-
tles, and 20 5,000-tablet bottles of green tablets, and 1 drum of 280,000
tablets, and 15 1,000-tablet bottles, 8 5,000-tablet bottleSj and 3 25,000-tablet
bottles of white tablets at Philadelphia, Pa.
RESULTS OF INVESTIGATION : The interstate shipment of the tablets was made
in bulk containers. After receipt of the shipment, a portion of the tablets
was repackaged into bottles and relabeled by the consignee.
Analysis showed that the green tablets contained not more than 62 percent
of the labeled amount of phenobarbital, whereas the United States Pharma-
copeia provides that phenobarbital tablets contain not less than 94 percent of
the labeled amount of phenobarbital. Further analysis showed that the white
tablets failed to meet the test specified in the United States Pharmacopeia
regarding permissible variation in the weight of individual tablets and the time
required by the tablets to disintegrate in water.
LABEL, IN PAST: (Bottle) "Phenobarbital y2 Grain * ? * * Green [or
"White"!."
NATURE OF CHARGE : Adulteration, Section 501 (b), the product purported to be
and was represented as "Phenobarbital Tablets," a drug the name of which
is recognized in the United States Pharmacopeia, an official compendium,
and the strength (green tablets) differed from, and the quality (white tablets)
fell below, the standard set forth in the compendium. The tablets were
adulterated when introduced into, while in, and while held for sale after
shipment in, interstate commerce.
DISPOSITION : November 29, 1951. Default decree of condemnation and
destruction.