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IA #66-70, 6/10/04, IMPORT ALERT, #66-70, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF CHLORHEXIDINE GLUCONATE ORAL RINSE (0.12%) MANUFACTURED BY
GERMIPHENE CORPORATION"

TYPE OF ALERT: Detention without Physical Examination (DWPE)

               NOTE: This import alert contains the Agency's current
               guidance to FDA field personnel regarding the
               manufacturer(s) and/or product(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.

PRODUCT:       CHLORHEXIDINE GLUCONATE ORAL RINSE (0.12%)

PRODUCT CODE:  62F--08

PROBLEM:       New drug without an effective new drug approval

PAC:           56008H

PAF:           AAP

COUNTRIES:          CANADA

MANUFACTURER:  Germiphene Corporation
               1379 Colborne Street, East
               P.O. Box 1748
               Brantford, Ontario, Canada N3T 5V7
               FEI# 3000166001

SHIPPER:       ALL

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 NEW DRUG

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.

CDER CONTACT:  Ada Irizarry  (301)827-8967

FOI:           No purging necessary

KEYWORDS:      Drugs, Unapproved

RECOMMENDING
OFFICE:        CDER, OC, Division of Drug New Drugs & Labeling Compliance,
               HFD-310

PREPARED BY:   Dave Krawetz, DIOP, HFC-170, 301-594-3872

DATE LOADED
INTO FIARS:         June 10, 2004