2605. Adulteration and misbranding of elixer of three bromides, tincture of
opium camphorated (paregoric), syrup of potassium guaiacolsulfonate,
and elixir of terpin hydrate and codeine. U. S. v. David M. Leff (Merit
Laboratories Co.). Plea of nolo contendere. Fine, $700. (F. D. C. No.
25581.    Sample Nos. 32-K, 33-K, 52-K, 10425-K, 15156-K.)
INFORMATION FILED : January 25,1949, Eastern District of Pennsylvania, against
David M. Leff, trading as the Merit Laboratories Co., Philadelphia, Pa.
ALLEGED SHIPMENT : Between the approximate dates of February 4 and March 2,
1948, from the State of Pennsylvania into the States of South Carolina, New
Fork, and Michigan.
NATURE OF CHARGE : Elixir of Three Bromides. Adulteration, Section 501 (b),
the article purported and was represented as "Three Bromides Elixir," a drug
the name of which is recognized in the National Formulary, an official com-
pendium, and its strength differed from the official standard since each 100 cc.
of the article contained less than 23 grams of total bromides, and the difference
in strength of the article from the standard was not stated on its label.
Misbranding, Section 502 (a), the label statements "Elixir of Three Bro-
mides N. F. * * * Each 100 cc Contains 8 Gm Ammoniated Bromide
* * * 8 Gm Potassium Bromide * * * 8 Gm Sodium Bromide" were
false and misleading since the article did not conform to the specifications of
the National Formulary and each 100 cc. of the article contained less than
24 grams of bromides.
Tincture of opium camphorated (paregoric). Adulteration, Section 501 (b),
the article purported to be "Camphorated Opium Tincture," a drug the name
of which is recognized in the United States Pharmacopoeia, an official com-
pendium, and its strength differed from the official standard since each 100 cc.
of the article yielded more than 45 mg. of anhydrous morphine and the differ-
ence in strength of the article from the standard was not stated on its
label. Misbranding, Section 502 (a), the label statement "Each fluid ounce
represents Opium powdered 1.83 gr." was false and misleading since the
statement represented that each fluid ounce of the article contained the
therapeutically active constituent of powdered opium, namely, anhydrous
morphine, in an amount not more than is present in 1.83 grains of powdered
opium, whereas each fluid ounce of the article contained the therapeutically
active constitutent of powdered opium in a larger amount than is present in
1.83 grains of powdered opium.
Syrup of potassium guaiacolsulfonate. Adulteration, Section 501 (b), the
article purported to be and was represented as "Potassium Guaiacolsulfonate
Syrup," a drug the name of which is recognized in the National Formulary, an
official compendium, and its strength differed from the official standard
since each 1,000 cc. of the article contained less than 75 grams of potassium
guaiacolsulfonate and the difference in the strength of the article from the
standard was not stated on its label. Misbranding, Section 502 (a), the label
statement "Syrup of Potassium Guaiacolsulfonate N. F. Each 100 cc. repre-
sents Potassium Guaiacolsulfonate 7.5 gm." was false and misleading since
the article did not conform to the specification of the National Formulary and
each 100 cc. of the article contained less than 7.5 grams of potassium guaiacol-
sulfonate.
Elixir of terpin hydrate and codeine. Adulteration, Section 501 (b), the
article purported to be and was represented as "Terpin Hydrate and Codeine
Elixir," a drug the name of which is recognized in the National Formulary,
an official compendium, and its strength differed from the official standard
since it contained less terpin hydrate and less codeine than required by the
standard and the difference in the strength of the article from the standard
was not stated on its label. Misbranding, Section 502 (a), the label state-
ments "Elixir Terpin Hydrate and Codeine N. F. * * * Active constitu-
ents in each 100 cc. Terpin Hydrate 1.7 gms. Codeine alkaloid 0.2 gms.," were
false and misleading since the article did not conform to the specifications of the
National Formulary and each 100 cc. of the article contained less than
1.7 grams of terpin hydrate and less than 0.2 grams of codeine alkaloid.
Further misbranding, Section 502 (f) (1), the labeling of all of the articles
failed to bear adequate directions for use since there was no statement in the
labeling of any condition, disease, or function for which the articles were
to be used.
DISPOSITION: February 16, 1949. A plea of nolo contendere having been en-
tered, the court imposed a fine of $700.