rS^^ 
FOOD AND DRUG ADMINISTRlrK^     j^y.^       ^      ^    j
NOTICES OF JUDGMENT UNDER THE F^RAL FOfctt
AND COSMETIC ACT
[Given pursuant to section 705 of the Food, Drug, and Cosmetic Act]
1351-1400
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 direction of the
Federal Security Administrator.
MAXJBICE COLLINS, Acting Administrator, Federal Security Agency.
WASHINGTON, D. C, December 21, 1945.
CONTENTS*
Page 
Page
Drugs actionable because of failure to bear
adequate directions or warning state-
ments 
      433
Drugs actionable because of deviation from
official or own standards  
-    449
Drugs and devices actionable because of false
and misleading claims    455
Drugs for human use.   -... 455
Drugs for veterinary use 
 466
Index 
_  470
DRUGS ACTIONABLE  BECAUSE  OF FAILURE TO BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS
1351. Misbranding of Doryl. U. S. v. Merck & Co., Inc. Plea of nolo contendere.
Fine, $15,000. (F. D. C. No. 11414. Sample Nos. 8475-F, 29923-F, 29926-F,
30384-F, 35242-F, 48851-F, 49311-F, 50487-F, 51266-F, 51571-F, 51618-F,
53252-F, 54015-F, 59510-F.)
The defendant prepared and sold a product under the name "Doryl" which
consisted of ampuls containing a solution of 0.25 milligram of carbamylcholine
chloride, dissolved in 1 cc. of water, intended for injection with a hypodermic
needle. The defendant also prepared and sold under the same name the product
involved in this case, which consisted of ampuls containing 0.15 gram of the same
drug in powder form and which was 600 times the amount of the drug contained
in the solution. The powder was intended for ophthalmologic use as eye drops.
The ampuls of the solution and the powder had a generally similar appearance,
the word "Doryl" being the most conspicuous word on both labels. A solution
containing the powder, if injected, would be lethal.
On December 19,1944, the grand jurors for the District of New Jersey returned
an indictment against Merck & Co., Inc., Railway, N. J., alleging shipment of a
number of ampuls of Doryl between the approximate dates of December 18,
1941, and May 11,1943, from the State of New Jersey into the States of Wisconsin,
Missouri,  California,  Florida,  Kentucky,  Ohio,  Pennsylvania,  Massachusetts,
?For failure to bear an accurate statement of the quantity of the contents, see Nos. 1354,1361,1376,1385,
1388,1393; deceptive packaging, Nos. 1351,1352,1392; omission of, or unsatisfactory, ingredients statements,
Nos. 1354,1379,1381,1391; inconspicuousness of required label information, No. 1358; failure to bear a label
containing the name and place of business of the manufacturer, packer, or distributor, No. 1361; substitution
of a drug, and its sale under the name of another drug, No. 1365; giving of a false guaranty, No. 1365; cos-
metics, subject to the drug provisions of the Act, Nos. 1359,1360,1391,1392.
679210-46- 1 
433
North Carolina, and Michigan. The article was labeled in part: (Ampul) "0.15
Gm.   *   *   *   Doryl   *   *   *    (Carbamylcholine Chloride Merck)."
Examination showed that the article possessed the composition declared on its
label.
The article was alleged to be misbranded (1) in that the labeling of the article
was misleading since the boxes and cartons containing the ampuls and the ampul
labels bore the statement "Do Not Use Intravenously," which suggested and
implied that other methods of injection were safe and appropriate, whereas other
methods of injection were not safe and appropriate, and the labeling of the article
failed to reveal the fact, material in the light of such labeling, that the article was
lethal when injected by any method; (2) in that the directions for use which
appeared on the labeling of the article, "Do Not Use Intravenously" and "Suffi-
cient to make 20 cc. of a 0.75? Solution for Ophthalmologic Use," were inadequate
since they failed to reveal that the article was not to be used for injection by any
method, but only in solutions for ophthalmologic use; (3) in that the labeling of
the article failed to warn against injection other than intravenously; and (4)
in that its container was so made, formed, and filled as to be misleading since the
container was in a form in which drugs intended for injection are customarily
packaged.
On February 2, 1945, a plea of nolo contendere having been entered on behalf
of the defendant, the court imposed a fine of $1,000 on each of 15 counts in the
indictment, a total fine of $15,000.