The following drug products were withdrawn or removed from the
market because such drug products or components of such drug products
were found to be unsafe or not effective. The following drug products
may not be compounded under the exemptions provided by section 503A(a)
of the Federal Food, Drug, and Cosmetic Act:
Adenosine phosphate: All drug products containing adenosine
phosphate.
Adrenal cortex: All drug products containing adrenal cortex.
Azaribine: All drug products containing azaribine.
Benoxaprofen: All drug products containing benoxaprofen.
Bithionol: All drug products containing bithionol.
Bromfenac sodium: All drug products containing bromfenac sodium.
Butamben: All parenteral drug products containing butamben.
Camphorated oil: All drug products containing camphorated oil.
Carbetapentane citrate: All oral gel drug products containing
carbetapentane citrate.
Casein, iodinated: All drug products containing iodinated
casein.
Chlorhexidine gluconate: All tinctures of chlorhexidine
gluconate formulated for use as a patient preoperative skin
preparation.
Chlormadinone acetate: All drug products containing
chlormadinone acetate.
Chloroform: All drug products containing chloroform.
Cobalt: All drug products containing cobalt salts (except
radioactive forms of cobalt and its salts and cobalamin and its
derivatives).
Dexfenfluramine hydrochloride: All drug products containing
dexfenfluramine hydrochloride.
Diamthazole dihydrochloride: All drug products containing
diamthazole dihydrochloride.
Dibromsalan: All drug products containing dibromsalan.
Diethylstilbestrol: All oral and parenteral drug products
containing 25 milligrams or more of diethylstilbestrol per unit
dose.
Dihydrostreptomycin sulfate: All drug products containing
dihydrostreptomycin sulfate.
Dipyrone: All drug products containing dipyrone.
Encainide hydrochloride: All drug products containing encainide
hydrochloride.
Fenfluramine hydrochloride: All drug products containing
fenfluramine hydrochloride.
Flosequinan: All drug products containing flosequinan.
Gelatin: All intravenous drug products containing gelatin.
Glycerol, iodinated: All drug products containing iodinated
glycerol.
Gonadotropin, chorionic: All drug products containing chorionic
gonadotropins of animal origin.
Mepazine: All drug products containing mepazine hydrochloride or
mepazine acetate.
Metabromsalan: All drug products containing metabromsalan.
Methamphetamine hydrochloride: All parenteral drug products
containing methamphetamine hydrochloride.
Methapyrilene: All drug products containing methapyrilene.
Methopholine: All drug products containing methopholine.
Mibefradil dihydrochloride: All drug products containing
mibefradil dihydrochloride.
Nitrofurazone: All drug products containing nitrofurazone
(except topical drug products formulated for dermatalogic
application).
Nomifensine maleate: All drug products containing nomifensine
maleate.
Oxyphenisatin: All drug products containing oxyphenisatin.
Oxyphenisatin acetate: All drug products containing
oxyphenisatin acetate.
Phenacetin: All drug products containing phenacetin.
Phenformin hydrochloride: All drug products containing
phenformin hydrochloride.
Pipamazine: All drug products containing pipamazine.
Potassium arsenite: All drug products containing potassium
arsenite.
Potassium chloride: All solid oral dosage form drug products
containing potassium chloride that supply 100 milligrams or more of
potassium per dosage unit (except for controlled-release dosage
forms and those products formulated for preparation of solution
prior to ingestion).
Povidone: All intravenous drug products containing povidone.
Reserpine: All oral dosage form drug products containing more
than 1 milligram of reserpine.
Sparteine sulfate: All drug products containing sparteine
sulfate.
Sulfadimethoxine: All drug products containing sulfadimethoxine.
Sulfathiazole: All drug products containing sulfathiazole
(except those formulated for vaginal use).
Suprofen: All drug products containing suprofen (except
ophthalmic solutions).
Sweet spirits of nitre: All drug products containing sweet
spirits of nitre.
Temafloxacin hydrochloride: All drug products containing
temafloxacin.
Terfenadine: All drug products containing terfenadine.
3,3',4',5-tetrachlorosalicylanilide: All drug products
containing 3,3',4',5-tetrachlorosalicylanilide.
Tetracycline: All liquid oral drug products formulated for
pediatric use containing tetracycline in a concentration greater
than 25 milligrams/milliliter.
Ticrynafen: All drug products containing ticrynafen.
Tribromsalan: All drug products containing tribromsalan.
Trichloroethane: All aerosol drug products intended for
inhalation containing trichloroethane.
Urethane: All drug products containing urethane.
Vinyl chloride: All aerosol drug products containing vinyl
chloride.
Zirconium: All aerosol drug products containing zirconium.
Zomepirac sodium: All drug products containing zomepirac sodium.
quoted from
List
of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons
of Safety or Effectiveness: Final Rule (
PDF
- 32KB) (3/9/1999)
