5484. Elixir Sedalet and penicillin tablets with sulfonamides.   F.D.C. No. 40655.
S. Nos. 67-551/3 M, 67-^557 M.)
QUANTITY : 720 btls. (lot No. 5881-VR), 45 btls. (lot No. 7264), and 45 btls. (lot
No. 7308) of elixir Sedalet, and 6 ctns., 24 btls. each, of penicillin tablets with
sulfonamides, at Falls Church, Va.
SHIPPED :    7-15-55, from Bethesda, Md., by Marshall Laboratories, Inc.
LABEL IN PAST: (Btls.) "Marshall One Pint (473 cc) Elixir Sedalet Each
Teaspoonful Contains: Phenobarbital ? gr. (16 mg.) Thiamin Chloride
5 mg." and "Pendiamer '200'   Brand of Penicillin Tablets with Sulfonamides
*?* * Each tablet contains:   Penicillin G Potassium Crystalline 200,000 U
*?* * Lot #5883."
RESULTS OF INVESTIGATION : Examination showed that the elixir Sedalet con-
tained (lot No. 5881-VR) 128 percent of the declared amount of phenobarbital
and (lot Nos. 7264 and 7308) less than 80 percent of the declared amount of
thiamine chloride, and that the penicillin tablets with sulfonamides contained
69.5 percent of the declared amount of penicillin and were labeled with the
expiration date "Feb. 1956."
LIBELED :   9-19-57, E. Dist. Va.
CHARGE:   Elixir Sedalet.   501(c)-when shipped, the strength of the article
differed from that which it was represented to possess since the article (lot
No. 5881-VR) contained more than ? grain of phenobarbital per teaspoonful /
and (lot Nos. 7264 and 7308) contained less than 5 mg. of thiamine chloride V
per teaspoonful; and 502(a)-the label statements (lot No. 5881-VR) "Each
Teaspoonful Contains * * * Phenobarbital ? gr." and (lot Nos. 7264 and 7308)
"Each Teaspoonful Contains * * * Thiamin Chloride 5 mg." were false and
misleading.
Penicillin tablets with sulfonamides. 501 (c)-when shipped, the strength
of the article differed from that which it was represented to possess since it
contained less than 200,000 units of penicillin G potassium crystalline per
tablet; 502(a)-the label statement "Each tablet contains: Penicillin G
Potassium Crystalline 200,000 U" was false and misleading; and 502(1) (2) -
the article purported to be and was represented as a drug composed in part of
penicillin and was from a batch for which a certificate issued in accordance
with regulations was not in effect.
DISPOSITION :   1-14-58.   Default-destruction.
DRUGS IN VIOLATION OF PRESCRIPTION LABELING REQUIREMENTS