2526. Adulteration and misbranding of phenobarbital sodium tablets and mis
branding of atropine sulfate tablets.    IT. S. v. 95 Bottles, etc.    (F. D. C.
No. 24838.   Sample Nos. 10221-K, 10223-K.)
LIBEL FILED :   May .12,1948, District of New Jersey.
ALLEGED SHIPMENT : On or about December 12, 1947, and January 7, 1948, from
Long Island Oity, N. Y. The phenobarbital sodium tablets were shipped by
Cole Laboratories, Inc., and the atropine sulfate tablets were shipped by the
Retort Pharmaceutical Co., Inc., a wholly owned subsidiary of Cole Labora-
tories, Inc.
PRODUCT : 214 bottles of phenobarbltal sodium tablets and 1,940 tubes of atropine
sulfate tablets at Royce, N. J. Examination showed that each bottle of the
phehobarbital sodium tablets contained less than half the declared number
of whole tablets, together with broken and disintegrated tablets; and that
each of the whole tablets contained 1.7 grains of phenobarbital sodium. Ex-
amination of 30 tubes of atropine sulfate tablets showed that they contained
from 20 whole tablets to as few as 9 whole tablets per tube, with the entire
30 tubes containing 543 whole tablets, together with broken, chipped, and
powdered tablets.
LABEL, IN PABT: "1000 Hypodermic Tablets each tablet contains 2 grains
(0.12 gm.) Phenobarbital Sodium U. S. P.," and "20 Hypodermic Tablets 1/150
Gr. each Atropine Sulphate U. S. P."
NATURE OF CHARGE: Phenobarbital sodium tablets. Adulteration, Section 501
(b), the strength of the article differed from the official standard. The United
States Pharmacopoeia requires that sodium phenobarbital tablets contain not
less than 90 percent of the labeled amount of sodium phenobarbital, whereas
each whole tablet of the article contained less than 90 percent of the declared
amount of sodium phenobarbital.
Phenobarbital sodium tablets and atropine sulfate tablets. Misbranding,
Section 502 (a), the statements "1000 Hypodermic Tablets" on the bottle label
of the phenobarbital sodium tablets and "20 Hypodermic Tablets" on the tube
label of the atropine sulfate tablets were false and misleading, since the bottles
and tubes contained fewer whole tablets than the declared number.
DISPOSITION :   June 21, 1948.   Default decree of condemnation and destruction.