6488. Procaine penicillin 6 in streptomycin sulfate in aqueous suspension.
(F.D.C. No. 44851.   S. No. 34-825 R.)
QUANTITY :   2,942 vials at New York, N.Y.
SHIPPED : On 3-31-60, from New York, N.Y., to Phoenix, Ariz., and returned to
New York on 6-9-60.
LABEL IN PAST: "10 cc. size 5 doses Procaine Penicillin G in Streptomycin
Sulfate in Aqueous Suspension."
RESULTS OF INVESTIGATION : Examination showed that the article was badly
discolored and lumpy; that it could not with certainty be uniformly resus-
pended; that withdrawal with a 22-gauge needle was nearly impossible; and
that the article contained substantially less than its labeled content of peni-
cillin and streptomycin.
LIBELED :    On or about 8-19-60, S. Dist. N.Y.
CHARGE: 501(C)-while held for sale, the strength of the article differed from
and its purity and quality fell below that which it purported and was repre-
sented to possess, since procaine penicillin G- in streptomycin sulfate in aque-
ous suspension is recognized in the Antibiotic Regulations (21 CFR 146a.67)
and it failed to conform to the standard set forth in such regulations since
it did not contain the potency represented and it was not in an aqueous
629973-62?2
suspension which, upon being shaken a reasonable length of time, would in-
sure a uniform distribution of solid in vehicle and, therefore, uniform and
proper dosage.
DISPOSITION :    9-20-60.   Default-destruction.