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U.S. Department of Health and Human Services

Import Alert 66-70
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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 # 66-70
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Chlorhexidine Gluconate Oral Rinse (0.12%) Manufactured By Germiphene Corporation"

Reason for Alert:
NYK-DO (BUF) and DET-DO have determined that recent shipments of drug products to the U.S. by the manufacturer and a former Canadian distributor included at least two shipments of undeclared chlorhexidine gluconate oral rinse (0.12%). Chlorhexidine gluconate oral rinse (0.12%) drug products appear to be unapproved new drugs under 201(p) and 505(a).

Guidance:
Districts may detain without physical examination all shipments of chlorhexidine gluconate oral rinse (0.12%) manufactured by Germiphene.

Product Description:
Chlorhexidine Gluconate Oral Rinse (0.12%)

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 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
Germiphene Corporation
Date Published : 09/10/2009

1379 Colborne Street, East , Brantford, Ontario CANADA
62 F - - 08 Chlorhexidine HCl (Anti-Infective, Topical)
Date Published: 09/10/2009


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