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U.S. Department of Health and Human Services

Import Alert 66-53
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 66-53
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of Sodium Tetradecyl Sulfate Injection"

Reason for Alert:
Newark district received information that the referenced firms are illegally exporting sodium tetradecyl sulfate injection into the United States. >>1(B)>Elkins Sinn Inc., Cherry Hill, NJ <<

Guidance:
Districts may detain without physical examination 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.).

Product Description:
Sodium Tetradecyl Sulfate Injection

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)."

OASIS Charge Code - UNAPPROVED

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


CANADA
OMEGA Laboratories Ltd
Date Published : 09/10/2009

11 177 Hamon Street , Montreal, QC CANADA
66 R - P 99 Vasoconstrictor N.E.C.
Date Published: 09/10/2009

Notes:Sodium Tetradecyl Sulfate Injection, STD Injection, Thromboject 1% and 3% Injection

UNITED KINGDOM
S.T.D. Pharmaceutical Products Ltd.
Date Published : 09/10/2009

Fields Yard , Plough Lane , Hereford, UNITED KINGDOM
66 R - P 99 Vasoconstrictor N.E.C.
Date Published: 09/10/2009

Notes:Sodium Tetradecyl Sulfate Injection, STD Injection, or Thromboject 1% and 3% Injection

Vascular Products Ltd
Date Published : 09/10/2009

35 King Street , Bristol, UNITED KINGDOM
66 R - P 99 Vasoconstrictor N.E.C.
Date Published: 09/10/2009

Notes:Sodium Tetradecyl Sulfate Injection, STD Injection, or Thromboject 1% and 3% Injection

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