3668. Adulteration and misbranding of sodium chloride solution, procaine hydro
chloride solution, and Darrow's solution.   U. S. v. Continental Pharma-

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cal Co. and Lawrence W. Jordan. Pleas of nolo contendere. Corpora-
tion fined $1,000; individual defendant fined $250. (F. D. C. No. 30604.
Sample Nos. 14748-K, 47674-K, 54856-K, 66834-K, 74522-K.)
INFORMATION FILED : On or about July 19, 1951, Northern District of Ohio,
against the Continental Pharmacal Co., a corporation, Cleveland, Ohio, and
Lawrence W. Jordan, president of the corporation.
ALLEGED SHIPMENT : On or about February 4, 1949, and February 1, April 13,
and May 25, 1950, from the State of Ohio into the States of Michigan, North
Carolina, Texas, and New York.
LABEL, IN PART : (Bottle) "1000 cc. [or "500 cc] Sodium Chloride 3? In Distilled
Water Each 100 cc. Contains : W/V Sodium Chloride U. S. P. 3.0 Gm. * * *
This product is sterile and non-pyrogenic. * * * The Continental Pharma-
cal Co. Cleveland, Ohio," "Procaine Hydrochloride 0.1? * * * Elach
100 cc contains: Procaine HC1 0.1 gm * * * ' Sterile Non-Pyrogenic,"
and "Darrow's Solution Each 100 cc. Contains W/V Sodium Chloride 0.4 Gm.
Potassium Chloride 0.26 Gm. Sodium Lactate 5.33 cc. of a Molar solution
*    *    *    This product is sterile and non-pyrogenic."
NATURE OF CHARGE: Sodium chloride solution. Adulteration, Section 501 (b),
the article purported to be "Isotonic Sodium Chloride Solution," a drug the
name of which is recognized in the United States Pharmacopeia, an official
compendium, and its strength differed from the standard set forth in that
compendium; and its difference in strength from the official standard was not
plainly stated on its label. Misbranding, Section 502 (a), the label statements
"Sodium Chloride 3? In Distilled Water Each 100 cc. Contains : W/V Sodium
Chloride U. S. P. 3.0 Gm." were false and misleading since the article contained
less than 3 percent of sodium chloride, and 100 cc. contained less than 3 grams
of sodium chloride.
Procaine hydrochloride solution. Adulteration (1 shipment), Section 501
(c), the strength of the article differed from that which it was represented
to possess in that it was represented to contain 0.1 percent of procaine hydro-
chloride and each 100 cc. was represented to contain 0.1 gram of procaine
hydrochloride, whereas it contained less than 0.1 percent of procaine hydro-
chloride and each 100 cc. of the article contained less than 0.1 gram of procaine
hydrochloride. Misbranding (1 shipment), Section 502 (a) the label state-
ments "Procaine Hydrochloride 0.1? * * * Each 100 cc. contains: Pro-
caine HCl 0.1 gm" were false and misleading since the article contained less
than 0.1 percent of procaine hydrochloride and each 100 cc. contained less
than 0.1 gram of procaine hydrochloride. Adulteration (remaining ship-
ment), Section 501 (c), the purity and quality of the article fell below that
which it was represented to possess since it was represented to be sterile,
whereas it was not sterile but was contaminated with viable micro-organisms.
Misbranding (remaining shipment), Section 502 (a), the label statement
"Sterile" was false and misleading since the article was not sterile.
Darrow's solution. Adulteration Section 501 (c), the strength of the article
differed from that which it was represented to possess since each 100 cc. was
represented to contain 5.33 cc. of a molar solution of sodium lactate, whereas
each 100 cc. of the article contained less than 5.33 cc. of a molar solution of
sodium lactate. Misbranding Section 502 (a) the label statement "Each
100 cc. Contains: * * * Sodium Lactate 5.33 cc. of a Molar solution" was
false and misleading since each 100 cc. of the article contained less than 5.33
cc. of a molar solution of sodium lactate.
DISPOSITION :    January 4, 1952.    Pleas of nolo contendere having been entered,
the court imposed a fine of $1,000 against the corporation and a fine of $250    ^
against the individual defendant.