3187. Misbranding of Private Formula tablets and Pruvo tablets.   U. S. v. 3
Drums, etc.    (F. D. C. No. 28008.    Sample Nos. 60449-K, 60450-K.)
LIBEL FILED :    September 29,1949, Eastern District of Wisconsin.
ALLEGED SHIPMENT: On or about September 22, 1949, by the Standard Pharm-
acal Co., from Chicago, 111.
PRODUCT : 3 drums containing 209,000 Private Formula tablets, together with
28 cases, each containing 6 dozen bottles of 75 tablets each, of Pruvo tablets
at Milwaukee, Wis., in possession of the Pruvo Pharmacal Co. The bottles
of Pruvo tablets, with each of which was enclosed a circular entitled "Pruvo,"
had been repacked from 3 drums of Private Formula tablets included in the
above-mentioned shipment. The bottles were labeled by the consignee, but no
written agreement existed between the shipper and the consignee as to
labeling such as is contemplated under Section 503 (a) of the Act and the
regulations thereunder.
LABEL, IN PAET: (Drums) "Private Formula No. P-25,897 Prepared for
Wm. SLK Laboratories * * * Each tablet represents: Calcium Succinate
3 gr. Aspirin 4 gr. Caution-to be dispensed only by or on the prescription
of a physician * * * This is a bulk shipment intended for repackaging"
and (bottle) "Pruvo Acetylsalicylic Acid 4 grains Calcium Succinate 3
grains   *    *    *   for Arthritic, Neuritic, Rheumatic Pain Relief."
NATURE OF CHARGE: Misbranding (tablets in drums), Section 502 (f) (1),
the labeling of the tablets failed to bear adequate directions for use. The
tablets were misbranded when introduced into and while in interstate
commerce.
Misbranding (tablets repacked into bottles), Section 502 (a), certain state-
ments on the bottle label and in the circular were false and misleading. The
statements represented and suggested that the article was adequate and ef-
fective for the treatment and cure of rheumatism and arthritis, whereas the
article was not adequate and effective for the treatment and cure of rheu-
matism and arthritis; and, Section 502  (e)   (2), the label of the article
failed to bear the common or usual name of each of its active ingredients
since acetylsalicylic acid is not the common or usual name of aspirin. The
article was misbranded in the above respects while held for sale after ship-
ment in interstate commerce.
DISPOSITION : November 21, 1949, and July 14, 1950. The Standard Pharmacal
Co., claimant for the 3 drums of the Private Formula tablets, and the Pruvo
Pharmacal Co., claimant for the 28 cases of Pruvo tablets, having consented
to the entry of decrees, judgments of condemnation were entered and the
court ordered that the tablets be released under bond for relabeling, under
the supervision of the Food and Drug Administration.