1464. Adulteration of aminophylline.    TJ. S. v. 172 Ampuls of Aminophylline.   De
cree of condemnation and destruction. (F. D. C. No. 14443. Sample No.
85208-F.)
On November 20, 1944, the United States attorney for the Eastern District of
Pennsylvania filed a libel against 172 ampuls, 20 cc. size, of aminophylline at
Philadelphia, Pa., alleging that the article had been shipped on or about Septem-
ber 29,1944, from New York, N. Y., by the Bstro Chemical Co.
The article was alleged to be adulterated in that it purported to be and was
represented as theophylline ethylenediamine injection (aminophylline ampuls),
a drug the name of which is recognized in the United States Pharmacopoeia, an
official compendium, but its quality and purity fell below the standard set forth
therein since the article was not free of undissolved material.
On February 20, 1945, the Estro Chemical Co., claimant, filed an answer which
alleged that the product, when manufactured, was in full accordance with the
then existing United States Pharmacopoeia and was free of undissolved material
at the time of shipment. However, the answer failed to deny the allegations of
the libel that the product, at the time of seizure, contained undissolved material
and therefore was adulterated. A motion for judgment was filed by the Govern-
ment's attorney, based on the insufficiency of the claimant's answer, and the
court, after consideration of the matter, entered judgment in favor of the Govern-
ment. On the same date, a decree of condemnation was entered against the
product, and it was ordered destroyed.