6442. Bacitracin.    (F.D.C. No. 45072.    S. Nos. 32-340 R, 32-451 R, 33-362/4 R,
36-101/2 R.)
QUANTITY :    734 ctnd. vials at New York. N.Y.
SHIPPED: Between 8-11-60 and 8-16-60, from Philadelphia, Pa., by Philadel-
phia Ampoule Laboratories.
LABEL IN PART: (Ctn. and ampul) "No. 2005 Bacitracin U.S.P. Sterile 50,000
Units For Intramuscular or Topical Use * * * Philadelphia Ampoule Labora-
tories, Philadelphia 23, Pa. * * * Lot No. 8018   Exp. Date 9-62."
LIBELED :    11-16-60, S. Dist. N.Y.
CHARGE: 501(b)-when shipped, the strength of the article differed from the-
strength set forth in the United States Pharmacopoeia for bacitracin; 502(a) -
the label statement "50,000 Units" was false and misleading as applied to a
product containing less than 50,000 units of bacitracin per ampul; and:
502(1)-the article purported to be, and was represented as, a drug composed
wholly or in part of bacitracin, and it was not from a batch with respect to
which a certificate or release had been issued pursuant to 507.
DISPOSITION :   12-27-60.   Default-destruction.
DRUGS IN VIOLATION OF PRESCRIPTION LABELING REQUIREMENTS
<>443. Dextroamphetamine sulfate tablets, pentobarbital sodium capsules, and
dextro-amphetamine sulfate with amobarbital tablets  and capsules.
(F.D.C. No. 45323. S. Nos. 29-662/4 R, 53-597 R, 53-600 R.)
?QUANTITY : 5 1,000-tablet btls. of dextro-amphetamine sulfate with amobarbital,
3 1,000-tablet btls. and 7 200-tablet bags of dextroamphetamine sulfate,
1 700-capsule btl. of pentobarbital sodium, and 1 btl., containing 541 capsules
of dextro-amphetamine sulfate with amobarbital, at Minneapolis, Minn., in
possession of Cedar Drug Co.
SHIPPED :   On unknown dates, from outside the State of Minnesota.
LIBELED :   1-4-61, Dist. Minn.
?CHARGE: 502(b)-while held for sale, all of the articles failed to bear a label
containing (1) the name and place of business of the manufacturer, packer,
or distributor, and (2) an accurate statement of the quantity of contents;
502(e)(1)-the label of the 7-bag lot failed to bear the common or usual
name of the drug; 502(f) (1)-the label of the 7-bag lot failed to bear ade-
quate directions for use; and 503(b) (4)-the label of the 7-bag lot failed to
bear the statement "Caution: Federal law prohibits dispensing without
prescription."
DISPOSITION :   2-16-61.   Default-destruction.
DRUGS AND DEVICE ACTIONABLE BECAUSE OF FAILURE TO BEAR
ADEQUATE DIRECTIONS OR WARNING STATEMENTS*