5500. Water for injection.    (F.D.C. No. 40324.   S. No. 58-099 M.)
QUANTITY :   142 vials at Kansas City, Kans.
SHIPPED :   3-18-57, from Philadelphia, Pa., by Addison Laboratories.
LABEL IN PART: (Vial) "100 cc. Multiple Dose Vial Water For Injection
A Ten Dose Container Pyrogen Free Contains: Phenol 0.5? Sterile * * *
Physicians & Surgeons Supply, Wichita, Kansas."
BESULTS OF INVESTIGATION : Water for injection is a drug recognized by the
United States Pharmacopeia. The U.S.P. monograph states under the heading
"Packaging and storage,"-"Preserve Water for Injection in single-dose con-
tainers holding not more than 1,000 ml. or in multiple-dose containers holding
not more than 30 ml. * * * Water for Injection containing no antibacterial
agent may be packaged in a multiple-dose container of not greater than 100
ml. size, provided the package is marketed in combination with a medicinal
preparation for parenteral administration for which it is to be the solvent."
Examination showed that each vial of the article was closed by a rubber
stopper which could be readily penetrated by the ordinary hypodermic needle,
thus the contents of the vial could be withdrawn without removal or destruction
of the closure.
LIBELED :   6-14-57, Dist Kans.
CHARGE: 502(g)-the article was a drug, the name of which is recognized in
the United States Pharmacopeia, an official compendium; and, when shipped,
the article was not packaged as prescribed therein, since it was in a multiple
dose container holding more than 30 ml. and it did not qualify for an exemption
from that packaging provision.
DISPOSITION :   7-24-57.   Default-destruction.