IA #66-53, 7/19/91
TYPE OF ALERT: AUTOMATIC DETENTION
PRODUCT : Sodium Tetradecyl Sulfate Injection
STD Injection or Thromboject 1% Injection and 3% Injection
PRODUCT CODE : 66R[]P[][]
HARMONIZED
CODE : N/A
PROBLEM : New Drug Without Approved New Drug Application (NDA)
PAC : 56008H
COUNTRY : Canada (CA,260), England (UK,925)
MANUFACTURER/
SHIPPER : Product: STD Injection
STD PHARMACEUTICAL DISTRIBUTOR:
Fields Yard VASCULAR PRODUCTS, LTD.
Plough Lane 35 King Street
Hereford HR4 0EL England Bristol BS1 4DZ England
Product: Thromboject 1% Injection
Thromboject 3% Injection
OMEGA LABORATORIES, LTD.
11,177 Hamon Street
Montreal, Canada H3M 3E4
MANUFACTURER
SHIPPER I.D.#: N/A
IMPORTER'S
I.D.# : N/A
CHARGE : "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be a new drug within
the meaning of Section 201(p) without an approved new drug
application pursuant to Section 505(a)."
RECOMMENDING
OFFICE : Import Operations Branch (HFC-131)
REASON FOR
ALERT : Newark district received information that the referenced firms
are illegally exporting sodium tetradecyl sulfate injection
into the United States. Elkins-Sinn Inc., Cherry Hill, NJ
holds the only approved NDA for this product. They claim that
since this product is intended for use by physicians, the
foreign firms may be mailing the product directly to
physicians in small quantities to avoid Customs/FDA
intervention.
INSTRUCTIONS : Automatically detain all entries of these products. Districts
should alert local Customs officals that this product may be
entering through both formal and informal entries (mail, small
shipments, etc.).
KEYWORDS : Sodium Tetradecyl, Thromboject, STD Injection, STD
Pharmaceutical, Vascular Products Ltd, Omega Laboratories
FOI : No purging is necessary.
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