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
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