FOOD AND DRUG ADMINISTRATION
NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT
[Given pursuant to section 705 of the Food, Drug, and Cosmetic Act]
3121-3140
DRUGS AND DEVICES
The cases reported herewith were instituted in the United States district courts
by the United States attorneys, acting upon reports submitted by the Federal
Security Agency.   Published by direction of the Federal Security Administrator.
PAUL B. DTJNBAB, Commissioner of Food and Drugs.
WASHINGTON, D. 0., Octooer 12,1950.
CONTENTS *
Page
Drug requiring   certificate  or re-
lease, for which none had been
issued. 
118
Drugs actionable because of failure
to bear adequate directions or
warning statements 
118
Drugs actionable because of con-
tamination with filth 
122
Page
Drugs and devices actionable be-
cause of deviation from official
or own standards 
122
Drugs and devices actionable be-
cause of false and misleading
claims 
125
Drugs for human use 
125
Drugs for veterinary use 
127
*For presence of a habit-forming narcotic without warning statement, see Nos. 3122-3125; failure to bear
a label containing an accurate statement of the quantity of the contents, Nos. 3122-3126; failure to bear a
label containing the name and place of business of the manufacturer, packer, or distributor, Nos. 3122,
3124-3126.
904960-50
XB,M.T, 
117
?   ?   -
ii aOIMI
 P?J.S.   ,.,,,.
iMK*
DRUG REQUIRING CERTIFICATE OR RELEASE, FOR
WHICH NONE HAD BEEN ISSUED 
 * 
3121. Misbranding of penicillin sodium.   U. S.'v. 6% Cartons, etc.    (F. D. C.
No. 23191.    Sample Nos. 64198-H, 64199-H.)
LIBEL FILED :    June 18, 1947, Southern District of New York.
ALLEGED SHIPMENT:    On or about May 13, 1947, by Barich, Inc., from East
Rutherford, N. J.
PRODUCT : 696 cartons, each containing 5 200,000-unit vials, and 9 cartons, each
containing 5   500,000-unit vials, of penicillin sodium at New York, N. Y.
LABEL, IN PART: (Cartons) "Penicillin Sodium Proctor * * * Proctor
Laboratories    475 Fifth Avenue   New York 17, U. S. A."
JMATUBE or CHARGE: Misbranding, Section 502 (a), the labeling of the article
was misleading since it failed to reveal the fact that Proctor Laboratories was
4iot the manufacturer of the article, which fact was material in the light of
the unmodified words "Proctor Laboratories" appearing in the labeling; and
the label statements "Lot No. 77 * * * Oct-1-48" on the 200,000-unit vials
and "Lot No. 90 * * * Oct 1 1948" on the 500,000-unit vials were mis-
leading since they represented and suggested that the article had been certified
under such identifying marks in accordance with regulations promulgated by
the Federal Security Administrator, whereas the article had not been so
certified.
Further misbranding, Section 502 (f) (1), the labeling of the article failed
to bear adequate directions for use; and, Section 502 (1), the article was
represented as a drug composed wholly of penicillin sodium, a derivative of
a kind of penicillin, and it was not from a batch with respect to which a
certificate or release had been issued pursuant to the law.
DISPOSITION : June 1,1950. The Proctor Laboratories having appeared as claim-
ant and subsequently having withdrawn its claim, judgment of condemnation
was entered and the court ordered that the product be destroyed.
DRUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR
ADEQUATE DIRECTIONS OR WARNING STATEMENTS*