6303. Supplement to notice of judgment on drugs and devices, No. 6003. Vita-
min Bu injection. F.D.C. No. 40930, S. No. 67-040 M.
The notice of judgment in the above-identified case is incomplete in that it
fails to report the order of dismissal with respect to the adulteration charge
under Section 501(b) and the basis upon which the claimant of the article,
Maizel Laboratories, Inc., consented to the entry of a decree of condemnation.
In order that the notice of judgment may reflect these facts, the provisions
of the decree of condemnation are set forth below in their entirety:
IN THE  UNITED  STATES DISTRICT COURT FOR THE DISTRICT OF
MARYLAND
UNITED STATES OF AMERICA
Civil No. 10122
CONSENT   DECREE   OF
CONDEMNATION
144 vials, more or less, of an article of drug
labeled in part:
"Intramuscular 10 c.c. Intravenous VITAMIN
Bu,   INJECTION   Cyanocobalamin   U.S.P.   1000
meg. Each c.c. contains a sterile solution of 1000
micrograms Vitamin BM U.S.P. (Cyanocobalamin)
in normal  saline with 2?  Benzyl Alcohol as
preservative. * * * 28590 * * *."
"On November 1, 1957, a Libel of Information against the above-described
article was filed in this Court on behalf of the United States of America
by the United States Attorney and Assistant United States Attorney for
this District. The Libel alleges that the article proceeded against is a
drug which is violative of the Federal Food, Drug, and Cosmetic Act, 21
U.S.C. 334 in that it was adulterated when introduced into and while in
interstate commerce within the meaning of 21 U.S.C. 351(b) and that it
is a New Drug which may not be introduced or delivered for introduction
. into interstate commerce under the provisions of 21 U.S.C; 355(a) since
an application filed pursuant to 21 U.S.C. 355(b) is not effective with respect
to such drug. Pursuant to Monition issued by this Court, the United States
Marshal for this District seized said article of drug on November 5, 1957.
Thereafter, Maizel Laboratories, Inc., of Chicago, Illinois, appeared as claim-
ant and filed answer to the Libel.
"Claimant, through its attorney, represents to the Court that the intrinsic
value of the drug under seizure in this case is negligible, and further that
the standard set forth in the United States Pharmacopoeia for this drug
has been clarified to include a specific test for solids, which test was not part
of the United States Pharmacopoeia monograph at the time of shipment,
and without admitting any of the issues of law and fact involved, claim-
ant consents that a Decree of Condemnation and Destruction may be entered
in this case pursuant to 21 U.S.C. 334, for violation of 21 U.S.C. 355.
"The Court being fully advised in the premises, and in view of claimant's
consent to condemnation and destruction of the seized drug for violation
of 21 U.S.C. 355, it being unnecessary to adjudicate the allegation of vio-
lation under 21 U.S.C. 351(b), and the parties having therefore agreed to
the dismissal of the allegation of violation under 21 U.S.C. 351(b) it is,
"ORDERED, ADJUDGED, AND DECREED that the article of drug under
seizure is violative of 21 U.S.C. 355, in that it is a New Drug which may not
be introduced or delivered for introduction into interstate commerce under
the provisions of 21 U.S.C. 355(a) since an application filed pursuant to
21 U.S.C. 355(b) is not effective with respect to such drug, and it is hereby
condemned pursuant to 21 U.S.C. 334(a) and that said article shall be
destroyed by the United States Marshal for this District pursuant to 21
tJ.S.0.334(d) ; and it is further
"ORDERED, ADJUDGED, AND DECREED, that the allegation of viola-
, tion under 21 U.S.C. 351(b) be; and hereby is dismissed; and it is further
''ORDERED, ADJUDGED, AND DECREED, pursuant to 21 U.S.C. 334(e),
that the libelant shall recover from the claimant all court costs and fees
and storage and other proper expenses to be taxed after destruction of said
? article of drug."
Dated thi910th day of August 1959.
"WV CALVIN CHESTNTJT,
United States District Judge.