5562. Del-Caps. (F.D.C. No. 41316. S. Nos. 70-416/8 M.)
QUANTITY : 1 drum containing 24,850 capsules, 1 drum containing 49,850 cap-
sules, and 1 drum containing 20,300 capsules at Philadelphia, Pa.
SHIPPED:   7-3-57, from Rensselaer, N.T., by Delmar Pharmacal Corp.
LABEL IN PART: (24,850-capsule lot) "Lot No. 2881 * * * Formula Del-Caps
10 Mg."; (49,850-capsule lot) "Del-Caps 15 Timed Disintegration Capsule
* * * Each Capsule Contains: Dextro Amphetamine Sulfate 15 mg. * * *
provides for the disintegration of the contents throughout a period of 6-10
hours" and "Lot No. 2974 * * * Formula: Del-Caps 15 mg."; (20,300-cap-
sule lot) "Lot No. 2974 * * * Formula: Del-Caps 15 mg.," "Del-Caps Time
Disintegration Capsules * * * Dextro amphetamine sulfate 10 mg. * * * pro-
vides for the disintegration of the contents throughout a period of 6-10
hours," and "Del-Caps 15 Timed Disintegration Capsule * * * Dextro am-
phetamine sulfate 15 mg. * * * provides for the disintegration of the contents
throughout a period of 6-10 hours."
RESULTS OF INVESTIGATION: Examination showed that the capsules in the
24,850-capsule lot contained 15 mg. per capsule of dextroamphetamine sulfate,
of which 80 percent was released within 1 hour rather than uniformly over a
6- to 10-hour period; that the capsules in the 49,850-capsule lot contained 15
mg. per capsule of dextro-amphetamine sulfate, of which 81 percent was re-
leased within 2 hours rather than uniformly over a 6- to 10-hour period; and
that the 20,300-capsule lot contained 10 mg. per capsule of dextro-ampheta-
mine sulfate, of which 90 to 99 percent was released within 2 hours rather
than uniformly over a 6- to 10-hour period.
;LIBELED:   1-3-58, E. Dist. Pa.
?CHARGE: 501(C)-when shipped, the quality of the article in all lots fell below
that which it purported and was represented to possess since the capsules
failed to disintegrate as indicated; 502(a)-the statement "Timed Disintegra-
tion Capsules * * * provides for the disintegration of the contents throughout
a period of 6-10 hours" on the labels of the 49,850- and 20,300-capsule lots was
false and misleading; 502(e) (2)-the label of the capsules in the 24,850-lot
failed to bear the common or usual name of each active ingredient; and
503(b)(4)-the capsules in the 24,850-capsule lot were a drug subject to
503(b)(1), and the label failed to bear the statement "Caution: Federal
law prohibits dispensing without a prescription."
DISPOSITION :   2-26-58.   Default-destruction.
DRUGS ACTIONABLE BECAUSE OF CONTAMINATION WITH FILTH