5327. Amobarbital sodium and phenobarbital sodium.   (F. D. 0. No. 39189.   S.
Nos. 17-585 M, 21-661M, 21-678 M.)
INDICTMENT RETURNED:   2-18-57, B. Dist. Pa., against Milton A. Calesnick,
t/a Addison Laboratories, Philadelphia, Pa.
ALLEGED VIOLATION: On 4-14-55, the defendant Caused to be given to a firm
engaged in the business of shipping drugs in interstate commerce an invoice
containing a guaranty that the ampuls of phenobarbital solium and amobarbi-
tal sodium covered by the invoice were not adulterated or misbranded within
the meaning of the Federal Food, Drug, and Cosmetic Act.
On 4-14-55, the defendant caused to be delivered to the holder of the
guaranty, at Philadelphia, Pa., under the above invoice, ampuls of Qhenobarbi-
tal sodium which were adulterated and ampuls of amobarbital sodium which
were adulterated and misbranded.
In addition, the defendant caused to be shipped, on 4-22-65, from Penn-
sylvania to Virginia a number of ampuls of amobarbital sodium which were
adulterated and misbranded.
LABEL IN PART: (Ampuls) "Amobarbital Sodium 7^ gr. {or "3? gr."]
Sterile-Intravenous" and "5 cc. Ampoule Sodium Phenobarbital Contains:
2 Grains-Dry Powder-Sterile-Intramuscular."
RESULTS OF INVESTIGATION : Examination of the amobarbital sodium showed
that some ampuls contained more and some ampuls contained less than the
labeled amount of amobarbital sodium. Examination of the phenoparbital
sodium showed that it contained more than the labeled amount of that ingre-
dient.
CHARGE: Phenobarbital sodium. 501 (b)-the article purported to be and was
represented as "Sterile Phenobarbital Sodium," a drug the name of which is
recognized in the United States Pharmacopeia, ah official compendium; and its
strength, when shipped, differed from the official standard since the average
weight of the content of phenobarbital sodium per ampul failed to comply with
the standard specified in the compendium.
Amobarbital sodium. 501 (b)-the article purported to be and was repre-
sented as "Amobarbital Sodium," a drug the name of which is recognized in the
National Formulary, an official compendium, and its strength, when shipped,
differed from the official standard since the average weight of the content of
Amobarbital Sodium per ampul failed to comply with the standard specified in
the compendium; and 502 (d)-the article contained amobarbital sodium, a
chemical derivative of barbituric acid, which has been designated by regulations
as habit forming; and the label of the article failed to bear the statement
"Warning-May be habit forming."
PLEA :   Guilty.
DISPOSITION : 6-17-57. Defendant fined $2,000 and placed on probation for 3
years.
DRUG ACTIONABLE BECAUSE OF CONTAMINATION WITH FILTH