3852. Misbranding of Combisul tablets, Pentresamide tablets, and Seconal Sodium
capsules.   U. S. v. Riverhead Drug Co., Inc., and Edward A. Schwartz.
Pleas of guilty.   Fine of $250 against corporation and $750 against De-
fendant Schwartz.    Individual defendant placed on probation for 1
year.    (F. D. C. No. 31302.    Sample Nos. 91993-K, 24571-L to 24573-L,
incl., 24576-L.)
INFORMATION FILED :    September 10, 1952, Eastern District of New York, against
Riverhead Drug Co., Inc., Riverhead, L. I., N. Y., and Edward A. Schwartz,
president and treasurer of the corporation.
ALLEGED VIOLATION : On or about November 14,1950, and January 16,21, and 26,
1951, while a number of Combisul tablets, Pentresamide tablets, and Seconal
Sodium capsules were being held for sale at the Riverhead Drug Co., Inc.,
after shipment in interstate commerce, Riverhead Drug Co., Inc., and Edward A.
Schwartz caused various quantities of the drugs to be repacked and dispensed
without a physician's prescription, which acts resulted in the repackaged drugs
being mlsbranded.
NATURE OF CHARGE: Misbranding, Sections 502 (b) (1) and (2), the repack-
aged drugs failed to bear labels containing the name and place of business of
the manufacturer, packer, or distributor, and an accurate statement of the
quantity of the contents; and, Section 502 (f) (1), the labeling of the repack-
aged drugs failed to bear adequate directions for use.
sules contained a chemical derivative of barbituric acid, which derivative
has been found to be, and designated by regulations as, habit forming; and
the capsules failed to bear a label containing the name, and quantity or propor-
tion of such derivative and in juxtaposition therewith the statement "Warn-
ing-May be habit forming."
Further misbranding, Section 502 (e) (2), the repackaged Combisul tablets
and Pentresamide tablets failed to bear labels containing the common or usual
name of each active ingredient of the tablets; and, Section 502 (f) (2), the
repackaged Combisul tablets and Pentresamide tablets failed to bear labeling
containing adequate warnings against use in those pathological conditions
where their use may be dangerous to health, and against unsafe dosage and
duration of administration, in such manner and form, as are necessary for the
protection of users.
DISPOSITION : December 12, 1952. Pleas of guilty having been entered, the
court imposed a fine of $250 against the corporation and $750 against Defendant
Schwartz and placed the individual on probation for 1 year.