IA #66-41 - 9/28/00 REVISION OF IMPORT ALERT #66-41 "UNAPPROVED NEW DRUGS
PROMOTED IN THE U.S." ATTACHMENT REVISED 11/10/04
NOTE: This revision updates the alert into the current format.
Additional changes are bracketed by asterisks (***).
TYPE OF ALERT: ***Detention Without Physical Examination (DWPE)***
(Note: This import alert contains guidance to FDA field personnel only. It
does not establish any requirements, or create any rights or obligations on
FDA or on regulated entities.)
PRODUCT: Unapproved new drugs
PRODUCT
CODE: ***See attachment***
PROBLEM: Unapproved drugs promoted in the U.S.
***OASIS
CHARGE CODE: UNAPPROVED***
***PAF: AAP (Approvals)***
***PAC: 56008H
63001***
COUNTRY: All
MANUFACTURER/
SHIPPER: See attachment
REFERENCE: ***Regulatory Procedures Manual Chapter 9, Subchapter
"Coverage of Personal Importations" issued 12/11/89. (Note:
This subchapter, previously designated as RPM 9-71, was
issued to consolidate guidance that previously existed in
RPM Chapters: 9-71, "Mail Importations" and Chapter 9-72,
"Coverage of Importations Contained in Personal Baggage,"
and the Pilot Guidance for Release of Mail Importation dated
July 29, 1988.)***
***Compliance Policy Guide (CPG) 120.500 (formerly 7150.10)
gives extensive background on health fraud, and the indirect
risks of relying on unproven remedies. Health fraud has
been defined by the agency as the promotion of unproven
medical products.***
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 effective new drug
application (NDA)[Unapproved New Drug, Section 505(a)".]
RECOMMENDING
OFFICE: Division of Import Operations and Policy (HFC-170)
REASON FOR
ALERT: Media reports concerning FDA'S guidance for release of
importations for personal use have inaccurately suggested
that any unapproved drug may be imported through the mail
for personal use. The pilot guidance and subsequent
Regulatory Procedures Manual Subchapter, "Coverage of
Personal Importations," that issued is much more restrictive
than reported. The RPM subchapter provides guidance for use
in those instances in which field personnel determine that
the exercise of discretion regarding the admissibility of an
unapproved drug might be appropriate. The guidance is by
its very terms discretionary, and does not provide anyone
with a right to import any drug.
The guidance provides that release of an unapproved drug for
personal use may be appropriate if, among other
considerations, the drug is intended for a serious condition
for which effective treatment may not be available
domestically either through commercial or clinical means,
and it is not considered to represent an unreasonable risk.
The guidance is intended to apply only to: (1) persons who
have received treatment in a foreign country with an
unapproved drug which is not available in the United States,
and who, upon returning to the United States, have imported
the drug for their personal use in an effort to continue the
treatment started abroad; and (2) persons who have made
their own arrangements for obtaining an unapproved drug from
foreign sources, when the drug has not been promoted in the
United States.
***When there is evidence of promotion of unapproved drugs
to persons in the United States, the products should be
considered for detention. Evidence of promotion may consist
of solicitations for mail orders, press releases,
advertising materials, and other public announcements that
are directed to persons residing in the U.S.***
***The subchapter of the RPM on coverage of personal
importations provides guidance for FDA personnel on when it
is appropriate to recommend import alerts involving
unapproved products likely to be imported for personal use.
Such recommendations are appropriate when an unapproved
product represent a health fraud, as defined in CPG 120.500
or an unapproved foreign product is promoted for mail-order
shipments. Thus, the field may recommend an import alert
when an unapproved product poses either a direct health risk
or indirect health risk.***
GUIDANCE: Districts may detain without physical examination any
unapproved drug listed in the attachment.
***Districts may also detain without physical examination
any other unapproved drug that fails to meet the
discretionary release criteria in the RPM. When detained
products that appear to meet these criteria and are not
listed in the attachment, districts should forward
documentation to DIOP for consideration for inclusion in
this alert.***
SPECIAL NOTE: Districts should continue to enforce, as appropriate,
related import alerts restricting fraudulent, dangerous, and
commercial unapproved drug importations.
FOI: No purging required.
KEYWORDS: New drugs, unapproved new drugs
PREPARED BY: DIOP, Operations and Policy SDWG: HFC-172, (301) 443-6553
DATE LOADED
INTO FIARS: September 28, 2000
ATTACHMENT TO IMPORT ALERT #66-41 11/10/04
Unapproved new drugs that may be subject to DWPE
Although Gamma Hydroxybutyrate (GHB) has been identified as an unapproved new
drug and covered in this import alert, effective March 13, 2000, GHB was
classified as a Schedule I Controlled Substance and under DEA authorization.
Therefore, entries of GHB, or its analogue GBL should be returned to Customs
for appropriate disposition. (GBL and related substances can be treated as
controlled substance analogues, and as Schedule I Controlled Substances, if
intended for human consumption).
Manufacturer Product/Product Codes
Chempropack BV "G-Spot"
Donker Duyvisweg 45 65V50 and 65V51
Dordrecht, 3316 BL, Netherlands GPI = VI
FEI# 3002854125 3/30/00
Products shipped by the following firms were found to contain the drugs
glyburide and phenformin, which are used to treat diabetes. These products,
being promoted as dietary supplements claiming to contain only natural Chinese
herbal ingredients, are available through mail order and can be purchased by
telephone or via the Internet. These products are being recalled under a Class
I recall as a health hazard.
PRODUCT SOURCE COUNTRY
All Products Harbin Dong Fang International China
GPI = DR Trading Corp. 2/24/00
GPI = VI No. 68 Dong Feng St. Dist. Harbin
Aphin, China
FEI# 3002158294
All Products China Hua Yang Technology & Trade China
GPI = DR Corp. 2/24/00
GPI = VI No. 13, South Xin Hua St., He Ping Men
Beijing 10052, China
FEI# 1000280039
PRODUCT SOURCE COUNTRY
"Alpecin Special" Continental Cosmetics, Ltd. Canada
Vitamin Hair 390 Millway Ave.
Lotion Concord, Ontario,
L4K 3V8 (Shipper)
Canada
MID #XOCONCOS390CON
Alcina Bielefeld Germany
(Manufacturer)
MID #DEALCBIE
Alcina Cosmetic Belus
BVBA/SPRL
Spaoi s.r.l.
GE, Italia Italy
(Distributor)
MID #ITALCCOSGEN
Alcina Cosmetic Netherlands
Nederland B V (Distributor)
MID #NLALCCOSUNK
Calfcart Attogram Corp. Canada
(calf cartilage 12295 Hwy 50, RR#3 8/19/94
cream) Bolton, Ontario
MID# CAATTCOR1229BOL
PRODUCT SOURCE COUNTRY
"Crino Pouss" Altesse Cosmetique, Inc. Canada
Capillary Serum BP452BR
with Placenta Montreal, Que. Canada
H2S 3M3 Canada
MID #XQALTCOS452MON
Buffalo district recently detained two hair lotions products which were
labeled with claims of anti-hair loss. The district detained the products
based on violation of 21 CFR 310.527(b) in that the products were represented
as external hair loss prevention lotions which is regarded as a new drug
within the meaning of section 201(p) for which a new drug application (NDA)
under section 505 is required for marketing.
The shipments were commercial size entries which appeared to be for
distribution and sale in the U.S.
Dextran Sulfate Polydex Pharmaceuticals, Ltd. Canada
"Formula 101" Manufacturer: China
"Beijing Zhangguang" General Factory of
Hair Regrowth Liniment Beijing Zhangguang Hair
Regrowth Liniment 725, Area 7, Jim Song Xi,
Chagyang, Beijing, China
Shipper: Canada
International
Health Organization
(aka - R&R; International)
Cornwall, Ontario, Canada
Kamagra (Sildenafil Ajanta Pharma Limited India
100 mg. oral tablet) 318 Linking Road 04/4/03
65PD[]02 Mumbai, India
FEI #1000446587
Laetrile All Firms All Countries
also known as: amygdalin, 01/14/00
Vitamin B-17 (100 mg & 500 mg tablets),
and "amigdalina" (ampules for injection)
Product Codes: 54E15, 54F15, 54Y05
Promoter/Distributor Canada
Life Crystals, Dr. Ravi Devgan
oral 32 oz. Life Crystals,
5 cc I.V. Chondriana, (dba: The Total Wellness Center
6 cc I.V. 42 Redpath Avenue
Immumostim LV047 Toronto, Ontario, Canada, M4S 2J6
MID# XORAVDEG42TOR
METBAL
Metabolic Balance
vitamin Metabolic balancing
serum used for a verity of
conditions such as cancer,
diabetes, lupus, etc.
AND
PRODUCT SOURCE COUNTRY
Organotherapy- The Total Wellness Center Canada
(Live Cell 21219 Woodbine Avenue
Fractions Therapy) R.R. 1, Queensville, Ontario
Shark cartilage) L0G 1R0
CAR-T-Cell Canada
Natcell M - mesenchyme MID# XOTOTWEL2121QUE
Natcell C- cerebrum
Natcell T - thymus
AND
Distributor
NaturPharm Inc.
Address Unknown
AND
Promoter
Dr. George Merkl, President Canada
Consumer Health Organization
of Canada
250 Sheppard Avenue
Willowdale, Ontario,
M2N 5S9, Canada
AND
Distributor
Life Crystals Dr. Villalpando Mexico
Address Unknown
(Note: Some or all of the above identified products are perhaps being shipped
by the shippers/distributors/promoters so identified)
All the above products are reported to be used in a treatment regimen promoted
by The Total Wellness Centers, one of which is operated by Dr. Ravi Devgan.
Available literature promotes the procedure as effective for the treatment of
AIDS, Epstein Barr Virus and cancer, by cleansing the blood. A video tape,
entitled "New Frontiers in Molecular Biology Life Crystal Capturing the Sun"
promotes use of these products and is narrated by Dr. Merkl, who is also the
President of ^
^.
Cancer treatment - Drogueria Samuel Hahneman Colombia
(Product purportedly Fundacion Palcossio
made from extracts of Carrera 42 E. NO. 88-20
turkey-buzzard Barranqiulla, Colombia
(vulture) and
reinforced with 333
anticancer plants.
All Drugs International Products West Germany
7000 Stuttgart 1
*Adrenal cortex All All
extract
PRODUCT SOURCE COUNTRY
*(It should be noted that these products are also covered under Import Alert
#66-08 "Drug Products Containing Adrenal Cortex Extract or Adrenal Cortex
Injection".)
*Adrenal cortex All All Injection
All Drugs Interlab, Luzerner Str. 28 Switzerland
CH-6330-CHAM-2G
Interlab, Serco Ex Via
Cantonale 42, CH-6948
Porza-Lugano
Interlab, Newport, England England
Pagnell, Bucks MK 16 8AA
All Drugs Pharmaceutical International Mexico
Artrilan Tablets Offenbach Mexicana Mexico
(contains prednisone,
salicylamide, and
meprobamate)
Zone Generators All All
Polyerga HorFerVit West Germany
Pharma GMBH
Hormone Fermente
Vitamine
Wehdestrabe 16
D-2900 Oldenburg,
West Germany
Zellen Live Cell Zellen Cell Pharmaceuticals Mexico
Therapy (and all Apartado Postal No. 1118 (10/22/92)
other products) Tijuana, B.C. Mexico
C.P. 22000
Zellyn Cell Research Oxygenesis Live Cell Therapy Bermuda
P.O. Box HM 1120 (and all other products) (4/21/94)
Hamilton, HMEX Bermuda
MID# BMZELCEL1120HAM
***Energy Complex*** A.G.E.S. Distribuidora Mexico
Apartado Postal No. 2603
Tijuana, B. C., Mexico
C.P. 22000
ID# MXAGEDIS2603TIJ
Nutri-Mail Mexico
Apartado Postal No. 8-F 6/19/96
Tijuana, B.C., Mexico 22540
MID# MXNUT8TIJ
***Note: Product may also be shipped from Inter-Medica of Tijuana, B.C.,
Mexico. This firm was identified for similar promotion in Bulletin IB#66-08,
10/26/87, for Neutralizer G.H, a weight loss product.***
PRODUCT SOURCE COUNTRY
Beta-Interferon CORNE,S.A. de C.V. Mexico
(Trade name FRONE TM) Rio San Lorenzo No. 623
(Alternate names- Col. Puentes del Valle
Rebif (TM) Garza Garcia, Nuevo Leon
R-FRONE ) 66220, Mexico
Manufacturer:
Serono Laboratories
Mexico
SAN-DO received promotional literature for the purchase of the above
referenced product. The literature identifies the product for the treatment
of Multiple Sclerosis and implies it is similar to the approved Interferon
beta-1b approved for use in the U.S.
The product is shipped via UPS upon receipt of a doctor's prescription. The
shipment includes FRONE TM 3,000,000 U.I. with dilutent, etc. for $200.
Information from the manufacturer of the approved Beta-Interferon to be sold
in the U.S., indicates this product appears to be half the strength of the
U.S. recommended therapeutic dose.
MIN-DO received promotional literature for the purchase of the above
referenced product from A.G.E.S. Distribuidora, Mexico. The literature
identifies the product as a "sexual breakthrough"; "potential benefits are:
Immediate energy and vigor, Reverses impotence in men of any age, ***"; "from
limp, standstill impotence to virility in as little as 48 hours"; etc.
Discretionary release of unapproved drug products promoted to individuals in
the U.S. is unacceptable under the Personal Importation Guidance of Regulatory
Procedures Manual Chapter 9-71.
All Drugs A. Werner & Co. Czechoslovakia
P.O. Box 615 9/23/93
111 21 Prague 1
Czechoslovakia
MID #: CSWERCO615PRA
All products Lenex Labs
Wavecrest House
West Bay St.
P.O. Box N-8174
Nassau, Bahamas
U.S. Distributor:
Alpha Omega Labs
Box 291
Fort Benton, Montana 59442
Boston District received promotional literature and mail order solicitation
for drugs from Alpha Omega Labs. The materials accompanied a letter from
Lenex Labs, in which Lenex stated that Alpha Omega would service orders on
Lenex's former products. The firms offer a variety of products, including
cancer inhibitors, weight loss products, and treatment for toxic bowel
symptoms.
PRODUCT SOURCE COUNTRY
*** All Drug Products Gero Vita International Canada
2255 B Queen Street East, Suite 820 4/6/95
Toronto, Ontario M4E 1G3 Updated
Canada 8/18/97
MID# XOGERVIT2255TOR
FEI# 1000327472
Gero Vita International (may be doing business as)
Life Force Laboratories 12/5/97
2255 B Queen Street East, Suite 820
Toronto, Ontario M4E 1G3
Canada
FEI# 3001190383
Gero Vita Laboratories 11/4/97
130A Denison Street
Markham, Ontario, Canada L3R 1B6
FEI# 30001146884
***NOTE: Gero Vita Laboratories is currently listed on the attachment to
import alert 66-41 for their promotion and distribution of "Prostata".
Evidence has been provided to FDA which indicates the firm is also promoting
and distributing to individuals in the U.S. numerous other drug products
(including but not limited to: GH3 (enhances memory);Testerex (enhances
sexual vitality); SOD Complex (fights disease causing free-radicals);
Medi-Zyme N (anti-inflammatory); Serezac (helps alleviate depression); Lung
Support Formula (moistens lungs & breaks up sputum; strengthens kidneys); Vita
Potencia (protects heart health; helps control stress); ACF 223 (reduces risk
of heart disease, cancer);etc.) which would be considered unapproved new
drugs.
Gero Vita Laboratories 2/14/00
4936 Yonge Street
Toronto, Ontario, Canada M2N 6S3
FEI# 3002084064
Thalidomide All All
8/9/95
Product codes for EEPS Screening: (Note the following product
codes should not be considered all inclusive of possible drug
codes that may be used to identify this product):
65V--40 - Thalidomide
65V--99 - Sedative, N.E.C.
66M--99 - Tranquilizer, N.E.C.
66V--99 - Miscellaneous, Patent Medicines, etc.
PRODUCT SOURCE COUNTRY
FDA has determined that Thalidomide is entering the U.S. and is being promoted
for use in treating various serious illnesses, including AIDS, cancer, and
rheumatoid arthritis. Thalidomide is a drug with significant and serious
health risks including such conditions as birth defects and peripheral
neuropathy. Due to the serious health risks associated with use of this drug
in inadequately controlled settings, it should be considered inappropriate for
release under the Personal Importation Guidance. Districts encountering
entries of Thalidomide should determine if the article is being entered under
an approved IND.
(Districts should contact the Center of Drug Evaluation and Research, Division
of Anti-Viral Drug Products, HFD-530 -301-443-09553 , Matthew Tarosky or
Brenda Atkins, for verification of IND status.)
Quantrol I Quantrol Research Institute Dominican
Quantrol II Ave. Sarasota Edificio Republic
(or CanCell) Embajador Edif. E, 8-I 12/22/95
(May be invoiced as Santo Domingo 99999
water) Dominican Republic
PRODUCT CODE: 62I99 aka Quantrol Agency or Quantum Research
INTERNATIONAL TRADE Live Cell Therapy Mexico
Apartado Postal No. 81 GPI=DR 2/9/96
Admon. de Correos Mesa De Otay
Mexico CP 22500
MID:MXINTTRA81ADM
FEI:1000481446
Information submitted to DIOP by ATL-DO indicates the above firm is soliciting
individuals to purchase Live Cell Therapy. The product is currently on import
alert from other shippers and under the name of Zellen Live Cell Therapy. The
Live Cell Therapy is being promoted for numerous medical conditions, including
aging problems, lack of energy, impotency, diabetes, degenerative brain
disease, etc. Promotion is usually accompanied by a MEMO FROM DR. HANZ BYRON
PREMATURE AGING SPECIALIST, HOLISTIC HEALTH CENTER LONDON, ENGLAND, ZURICH,
SWITZERLAND.
OTC-TRANSDERMAL PATCHES ALL ALL
FOR WEIGHT CONTROL 8/6/96
There has been an increase in the promotional advertising for OTC transdermal
patch products claiming they are effective for weight control. Health Fraud
Bulletin #13, dated February 3, 1989, regards OTC transdermal patch drug
products as unapproved new drugs and misbranded drugs, because of the method
of administration. (DRND/MLLM) (Product Code-66V[][]99)
(Note: Nicotine transdermal patch drug products are now acceptable for OTC
marketing via approved NDAs)
(Note: One firm in Canada has been identified as currently promoting such
patches-United Research Center, 1414 Place Bonaventure, Montreal, Quebec,
Canada, H5A 1H3 (FEI #1000595188,
MID #XQUNIRES1414MON) under the name of "The Svelt Patch")
PRODUCT SOURCE COUNTRY
All over-the-counter (OTC) vaginal 65X[][]01, 65X[][]02,
contraceptive drug products (including 65X[][]03, 65X[][]04,
contraceptive sponges) NOT labeled for 65X[][]99
"immediate use" (immediate use = less 6/16/97
than one hour prior to intercourse) and
not the subject of an approved new
drug application (NDA).
Liquid Deprenyl Citrate Discovery Experimental and Mexico
(Finished product) Development Mexico, N.A. 7/1/97
Juan Carrisco no. 13
GPI = DR Tijuana, B.C., Mexico
FEI# 3000326275
AND
Deprenyl (bases and salts) All Sources All Countries
(common name = selegilene) 62J[][]99, 66Y[][]99 7/21/97
or similar anti-parkinson products
Ephedrine Hydrochloride Tablets Sun Labs. Ltd. Canada
60C[][]22 1700-1700 McLeod Road 9/16/97
Niagara Falls, Ontario, Canada
L2G 7K3
FEI# 3000928033
ALL IAS Ltd. Great Britain
P.O. Box 2995 10/17/97
Muswell Hill
London N10 2NA
Great Britain
FEI #3001047710
aka: Int'l Antiaging Systems
P.O. Box 337
Guernsey, Channel Islands
Great Britain
Super Concentrated Aloe Vera WLA 132 The Wolfe Clinic Canada
C-Max 5 Scotsville Road 12/17/97
Coral Calcium & Coral Calcium Gold Strathlorne, Nova Scotia
Cesium Calcium FEI# 3001109438
PRO-MAX PRODUCT CODE: 66V[][]99
Pak-of-Life
ANTI-AGING PILL (Multitabs) Conseils De Sante, S.A. Switzerland
PRODUCT CODE: 66V[][]99 P.O. Box 331 1/27/98
1211 Geneva 12
Switzerland
FEI# 3001366101
This product contains deprenyl, vinpocetin, ergoloid mesylates (hydergine),
procaine HCl, and hematoporphyrin.
OSMOPAK PLUS (Manufacturer - per label) Canada
61MBJ11 Laboratoire Charton Laboratories 3/26/98
Division Herdt & Charton Inc.
9393 Louis H. Lafontaine
Montreal, Quebec, Canada
FEI# 1000541169
PRODUCT SOURCE COUNTRY
(Shipper)
Distribution Rapiflex
759 Marie-Victorin
St. Bruno, Quebec, Canada
FEI# 3001019316
This product is used as a drawing salve for the inflammation of subcutaneous
tissues.
BM Oral Solution, Xiehe Group Co., Ltd. China (Mainland)
and any product 19-A-8 Sanhac Street 4/1/98
containing the Shenyang, Liaoning
ingredient China (Mainland)
Staphylococcin FEI #3001281354
Prescription Vitality Health Products Thailand
Drugs: C/O Nimit Pharmacy 8/13/98
Dexfenfluramine944 Rama 4 Road
Medroxyprogesterone Bangkok
Premarin Thailand
66V[][]99 FEI #3001715829
QUINICRINE HYDROCHLORIDE ALL FOREIGN All
FINISHED PRODUCT/ALL MANUFACTURERS 8/25/98
FORMS-TABLETS,
(CAPSULES, LIQUID, ETC./
(NOT BULK/RAW MATERIAL)
PRODUCT CODE-60W[][]34
Dermopura Acneiche Revivre Cosmetiques C.R.B. spa Italy
Treatment against Acne & Via Vallina Orticella, 34 12/3/98
scarring.(Product maybe 31030 Borso Del Grappa (TV),Italy
entered as a Cosmetic under FEI #1000484992
PC(53LC-03) As a drug
treatment it may be
entered as PC 64X--07
or 99 (acne drug products)
or as 66V--99 (Miscel. Patent Medicines)
NOTE: CDER has determined this product is being marketed over the internet and
promoted for use as a treatment against "acne and scarring". The active
ingredients listed include "azelaic acid". That ingredient offered as an OTC
acne treatment, is a new drug, requiring an NDA to obtain marketing
authorization and should not be promoted as an OTC product. This product also
appears to be in violation of the final rule (21 CFR section 333.301) covering
acne products. Questions regarding this product or other similar products
should be addressed to Constance E. Bulawka, OTC Compliance Branch, Division
of Drug Labeling and Nonprescription Drug Compliance, HFD-312, 301-594-1065.
PLEASE ADD THE ABOVE FIRM/PRODUCT TO THE ATTACHMENT OF IMPORT ALERT #66-41.
PRODUCT SOURCE COUNTRY
Serotril Sciences, International "Serotril"
125 A - 1030 Denman Street Active Ingredient
Suite 100 is Hypericum perforatum
Vancouver, B.C. which is St. John's
V6G 2M6 Wort - 2/9/99
Canada 54Y--64
FEI# 3002597084 54Y--99
NOTE: CDER has determined that this product is being promoted as an
alternative to prescription drugs such as Fen-Phen and Imipramine and is
intended to treat obesity and depression and claims to correct the
"biochemical cause of weight loss". The product is described as an MAO
inhibitor. MAO inhibitors are a class of antidepressant drugs which can pose
health risks to patients if certain dietary restrictions are not observed
during therapy.
PRODUCT/PRODUCT CODE SOURCE
GAMMA-BUTYROLACTONE (GBL) 65V--51 (SEDATIVE) ALL
(SYNONYMS FOR GBL) 3/19/99
2(3H)-FURANONE DIHYDRO
BUTYROLACTONE
4-BUTYROLACTONE
DIHYDRO-2(3H)-FURANONE
4-BUTANOLIDE
2(3H)-FURANONE
DIHYDRO
TETRAHYDRO-2-FURANONE
BUTYROLACTONE
1,4-BUTANEDIOL/65V--52(SEDATIVE) ALL
(Note: FDA has identified GBL products labeled as: Renewtrient; Revivarant or
Revivarant G; Blue Nitro or Blue Niro Vitality; GH Revitalizer; PRO-G; Gamma G
and Remforce. This list should not be considered all-inclusive.)
GAMMA HYDROXYBUTYRATE (GHB)/65V--50 ALL
(SYNONYMS FOR GHB)
SODIUM GAMMAHYDROXYBUTYRATE (NaGHB)
POTASSIUM GAMMAHYDROXYBUTYRATE (KGHB)
GAMMA HYDROXYBUTRIC ACID
SODIUM OXYBATE
4-BUTANOLIDE
4-HYDROXYBUTYRIC ACID
4-OHB
ETHYL 4-ACEBUTANOATE
(Note: FDA has identified GHB products labeled as: Alcover; Gamma-OH;
Smatomax-PM; Somsanit; Anectamine; Natural Sleep 500, etc. This list should
not be considered all-inclusive.)
GBL and GHB also have many street names. Some of the most common are: G;
Liquid E or Liquid X; Georgia Home Boy; Great (Grievous) Bodily Harm; Liquid
Ecstacy; Scoop; Water.
GBL related products have been associated with reports of at least 55 adverse
health effects, including Death. When taken orally, GBL is converted in the
body to gamma hydroxybutyrate or GHB. GBL products are sold in liquid and
powder form.
GBL and GHB products are promoted with claims to build muscles, improve
physical performance, enhance sex, reduce stress and induce sleep. These
products are very potent unapproved drugs and powerful hypnotic substances
known to produce significant and potentially dangerous sedating effects.
District may detain the above products without physical examination from all
sources. FDA is aware these products are being offered for importation using
various non-drug claims such as: "wood softener" "bubble bath", etc. Further,
GBL is a known ingredient for commercial floor strippers. Never-the-less,
unless evidence is provided to the district that supports the product for non-
drug use, the product should not be considered for release. These products
are also inappropriate for release under FDA's Personal Importation Guidance.
For additional background information on GHB, please refer to import alert 66-
60. Questions regarding GBL/GHB can be directed to CDER/Office of Compliance,
HFD-310, Bradford Williams, 301-827-7364.
All Products Meditalent Enterprises Ltd. Taiwan
GPI = DR 87 Hsin Sheng N Road 8/4/99
GPI = VI Taipei, Taiwan 11/17/99
FEI# 1000441748
Meditech Enterprise Co. Ltd. Taiwan
PO Box 58388 8/4/99
Taipei, Taiwan 11/17/99
FEI# 1000132804
Firm Product/Product Code
(Note: products may be entering as skin care
cosmetics, therefore, we are including the
product code "53LC---" (Skin Care Preparations)
along with appropriate drug codes:
64L--28 (Fluocinonide)
64L--06 (Betamethasone dipropionate)
64L--99 (Glucocorticoids, n.e.c.)
Pramil Srl Regge Lemon Gel
Milan, Italy .05% Betamethasone dipropionate
FEI # 3002619397 64L--06/53LC
10/15/99
Topvate Cream
.05% Clobetasol Propionate
64L--99/53LC
Movate Cream Esapharma
.05% Clobetasol propionate
64L--99/53LC
Omic Gel Espharma
.025 g Fluocinonide
64L--28/53LC
Duwin Pharmaceutical and Chemical Co. Ltd. Regge Lemon Gel
38 Denton Street .05% Betamethasone dipropionate
Lagos, Nigeria 64L--06/53LC
FEI #3002558741
10/15/99 Topvate Cream
.05% Clobetasol Propionate
64L--99/53LC
Topsone Gel
.05% Betamethasone dipropionate
64L--06/53LC
Omic Gel Edkeen
.025% Fluocinonide
64L--28/53LC
Topsovate Cream Edkeen
.05% Clobetasone butyrate
64L--99/53LC
M Movate Industries, Inc. Movate Cream - M - 10/15/99
Milan, Italy .050 g Clobetason propionate
FEI #3002823220 64L--99/53LC
Tecmomed s.r.l. Dermo-Gel plus - Techmomed
viale san gimignano, 2 .075% Fluocinonide
Milan, Italy 64L--28/53LC
FEI #3002606542
10/15/99 Neoprosone-Gel Forte
.05% Betamethasone and
.1% Neomycin Sulphate
64L--06/53LC
Lemonvate Cream
.05% Clobetasol propionate
64L--99/53LC
N.P. Italiana srl Top-Gel with Special Sunscreen Agent
Napoli, Italy .025% Fluocinonide
FEI #3002823229 64L--28/53LC - 10/15/99
M.C.A. Medical and Chemical Agency Prosone Gel MCA
Via Parini, 13 .05% Betamethason dipropionate
S. Vittore Olona 64L--06/53LC
Milan, Italy 20028
FEI #1000167943 Top-Gel Plus MCA
10/15/99 .025 g Fluocinonide
64L--28/53LC
Mitchell International Pharmaceuticals Ltd. Pro Beta-Zone
Unit 7 Kingston House Estate .05% Betamethasone dipropionate
Portsmout, Thames Ditton, UK 64L--06/53LC
FEI #1000480864
10/15/99 Beta-Vate
.05% Betamethasone dipropionate
64L--06/53LC
Mercury Top Gel
.05% Fluocinonide
64L--28/53LC
Topsone Gel
.05% Betamethasone dipropionate
64L--06/53LC
Omic Gel Edkeen
.025% Fluocinonide
64L--28/53LC
Topsovate Cream Edkeen
.05% Clobetasone butyrate
64L--99/53LC
Glaxo Wellcome Research & Development Dermovate Cream (25 gram tube)
Greenford Road .05% Clobetasol propionate
Greenford, Middlesex, UK UB6 0HE 64L--99/53LC
FEI #3000263379 10/15/99
Laboratoires Mitchell Srl. Dermacare Gel
Paris, France .05% Fluocinonide
FEI #3002823274 64L--28/53LC
distributed by: 10/15/99
Sears Pharmaceuticals & Chemicals Ltd.
Nigeria
FEI #3002823282
Mitchell Cosmetics Srl Regge Lemon Gel
6 Bis Chemin Byron Case .05% Betamethasone dipropionate
Postale 59 64L--06/53LC
Geneva, Switzerland
FEI #3002582140 Omic Gel Plus
10/15/99 0.025 g Fluocinonide and Neomycin Sulfate 0.05g
64L--28/53LC
All Products Alta Natural Herbs & Supplements Canada
GPI = DR 1148 -20800 Westminster Highway
GPI = VI Richmond, B.C., Canada V6V 2W3
3/23/00 FEI# 3000211393
Preventac Tablets, PremeTab, Formulex Canada, Inc. Canada
SomaTac, UriTab Caplets 5950 EST Chemin Cote-de-Liesse
60LBA05, 60LAA05 Ville Mont-Royal
54F- - 99, 54A- - 99 Quebec, Canada
5/19/00 FEI # 3002269313
PACKER/SHIPPER:
Ropack Inc.
10801 Mirabeau
Anjou, Quebec H1J 1T7
Canada
FEI # 3002674295
Products shipped by the following firms were found to contain the drug
glyburide, which is used to treat diabetes. These products are, being promoted
as dietary supplements & claim to contain only natural Chinese herbal
ingredients. They are available through mail order and can be purchased by
telephone or via the Internet. These products are being recalled under a Class
I recall as a health hazard.
All Products Heilongjiang Provincial Hechang China
GPI = DR Import and Export Co.Ltd.
GPI = VI Harbin, China
6/6/00 FEI# 3002799794
All Products Harbin Zhongshan Diabetes China
GPI = DR Research Institute
GPI = VI Harbin, China
6/6/00 FEI# 3003028087
Calidou Sun Lotion MFG. (per label) Canada
66P- - 99 Prodemdis Enr.
6/8/00 St. Hubert, Quebec
Canada
FEI # 3003030473
MFG. (per shipper):
Laboratories Confab, Inc.
4355 Sir Wilfrid Laurier
St. Hubert, Quebec J3Y 3X3
FEI # 1000610344
Catalysis, S.I. Blue Cap Spray Spain
Zurbano 39 Blue Cap Cream 6/29/00
Madrid, Spain 28010 Blue Cap Shampoo
FEI# 3002989319
Product Codes:
Blue Cap Spray (100 ml, 3.33 fl oz): 62SAQ99, 61SAQ01, 61HBQ05,
53E[][]06, 53J[][]02, 53L[][]06
Blue Cap Cream (50 g, 1.6 oz): 62SAJ01, 53E[][]06, 53L[][]03,
53L[][]06
Blue Cap Shampoo (150 ml, 4.99 oz): 61HBL05, 63SAL01, 53E[][]06,
53L[][]06
Mifepristone All All
65J[][][][]/ 9/28/00
65D[][][][]
FDA has determined that unapproved versions of mifepristone manufactured
outside the U.S. are being promoted in this country for use to end pregnancy.
Due to the risks to the safety of the user in inadequately controlled
settings, mifepristone should be considered inappropriate for release under
the Personal Import Guidance. Districts encountering entries of mifepristone
should determine whether the importer of record for the article being entered
is Danco Laboratories, LLC, New York, New York (distributor of the U.S.
approved product) or whether the article is being entered under an IND that is
in effect. In such circumstances (when the article is being imported by the
distributor of the U.S. approved product or under an IND that is in effect),
the article is outside the scope of this guidance.
(Districts should contact CDER for verification of IND status.)
Source Product/Product Code Country
M.C.A. Top-Gel Super Italy
Medical and Chemical Agency 0,03 g Fluocinonide 2/12/01
Via Parini, 13 64L--28/53LC
S. Vittore Olona
Milan, Italy 20028
FEI #1000167943
All drug & dietary De-Sjamaan Netherlands
supplement products Hommelseweg 170 10/7/02
GPI - DR/IND - 54 Arnhem, Netherlands 6821
FEI #3003671336
All products ALPHA - Aleppo Pharmaceuticals Industries Syria
GPI = DR Baron Street, P.O. Box 517 11/21/02
GPI = VI Aleppo, Syria
FEI #3003659034
The following sources/products have met the criteria for detention without
physical examination. Shipments are likely to be encountered through express
mail or courier operations.
Certain drugs have special safety restrictions on how they are distributed.
These restrictions include distribution limited to facilities (such as
hospitals) or physicians with special training or expertise; or requiring
certain medical procedures (such as pregnancy or blood testing) if the drug
will be used. The following drugs are subject to a restricted distribution
program. Due to the serious health risks associated with the use of these
drugs with inadequate control, shipments of these drug are inappropriate for
release under the personal importation policy. For questions, Districts
should contact Ada Irizarry at the Center of Drug Evaluation and Research,
Division of Prescription Drug Compliance and Surveillance, HFD-330 at 301-594-
0101.
PRODUCT/PRODUCT CODES SOURCE COUNTRY
Isotretinoin All All
64X 11
12/06/02
Other names: Accutane, *** Accutane Roche 40, *** Retinoic Acid, 13-cis-,
Roaccutane, Isotrex, Accure, Amnesteem, Antibiotrex, Isohexal, Isotrex
Eritromicina, Isotrexin, Nimegen, Oratane, Roaccutan, *** Sotret, Claravis ***
*** Somatropin Recombinant All All
64R 23
2/19/04
Other names: Humatrope, Somatropin, Biosynthetic; Growth Hormone Recombinant
***
*** Abarelix All All
60V--99
2/19/04
Other names: Plenaxis ***
Firm My Drugs Canada
Address Jonathan Valicenti, PO Box 370, 1250 University St.
Montreal, Quebec, Canada H3B 3B0
FEI# 3004452174
^ ^
Firm Pharmacy RX Drugs Inc.
Address 9 Sundown Court, Thornhill, Ontario, Canada L4J 3V4
FEI# 3004452183
^ ^
Firm PharmAnabolics
Address Karznik Pretrova, Wroclaw, 5548 Poland
FEI# 3004452189
^ ^
Firm Pilot Mound Pharmacy
Address Darcey Mosquin, Box 89, Pilot Mound, MB Canada R0G 1P0
FEI# 3004452193
^ ^
Firm The U.P.P. Group
Address 74 Perry Drive, Sylvan Lake, Alberta, Canada T4S 1K4
FEI# 3004452206
^ ^
Firm TAME
Address 404-250 McDermont Avenue, Winnipeg, Manitobal, Canada, R3B 0S5
FEI# 3004452213
^ ^
Firm The Dispensary
Address NT Lusk, 25 Hipwood St, Brisbane, 4170 Australia
FEI# 3004452215
^ ^
Firm Liberty Lifestyle Pty Ltd.
Address Managing Director, PO Box 103 Concord West, Sydney, NSW 2138
Australia
FEI# 3004452224
^ ^
Firm DiscountMeds Online Corp.
Address PO Box 1005, Grand Anse, St. Georges, Grenada
FEI# 3004452230
^ ^
Firm 1drugstore-online.com
Address 429 Rochor Road, Startech Holding Limited 188452 Singapore
FEI# 3004452234
^ ^
Firm Punta Internacional de las Americas SA
Address Punta Punta, Costado Este del AutoBanco Nacional, Ave 10
San Jose, 11111 Costa Rica
FEI# 3004452237
^ ^
Firm DB Group (BHPHARMACY)
Address BLK 820, Yishun Street 81 #06-656, Singapore 760820
FEI# 3004452239
^ ^
Firm Border Pharmacy
Address 26 Abasolo y Reforma, C.P. 919020 Mexico
FEI# 3004452241
^ ^
Firm My Drugs Canada
Address PO Box 370,1250 University St., Montreal, Quebec, Canada H3B 3B0
FEI# 3004452242
^ ^
Firm Universal Needs SJ Inc.
Address PO Box 370, 1250 University St., Montreal, Quebec H3B 3B0 Canada
FEI# 3004452246
^ ^
Firm Fraser Valley Online
Address PO Box 435, Abbotsford, British Columbia, Canada V25 5Z5
FEI# 3004452248
^ ^
Firm MedsCorp
Address Courty Aunan, Blc. 5-6, Office 6b, Nurburger, 27850 Germany
FEI# 3004452249
^ ^
Firm Defining Presence Marketing Group Inc.
Address Universal Needs SJ Inc., PO Box 370, 1250 University Street
Montreal, Quebec, H3B 3B0 Canada
FEI# 3004452254
^ ^
Firm 111 Drugstore.com
Address Unknown Street Address, Singapore
FEI# 3004452260
^ ^
Firm Abas Pharmacy
Address Lakeside Computer Source, Box 136, Camp Morton, MB R0C 0M0, Canada
FEI# 3004452261
^ ^
Firm Adv-Care Pharmacy Inc.
Address Amr Bannis, 50 Heathcote Ave.,Toronto, Ontario, Canada M2L1Z1
FEI# 3004452262
^ ^
Firm Rx Resources Inc.
Address Box 11 Group 100 RR2, Lorette R0A 0Y0, Manitoba, Canada
FEI# 3004452266
^ ^
Firm Aptecha Inc.
Address Box 1158, Stonewall, Manitoba R0C 2Z0, Canada
FEI# 3004452268
^ ^
Firm LePharmacy Inc.
Address 7310 Mountain Sights Ave., Montreal, QC, Canada H4P 2A6
FEI# 3004452269
^ ^
^ ^
Firm TCE Group Inc.
Address Amr Bannis, 50 Heathcote Ave., Toronto, Ontario, Canada M2L 1Z1
FEI# 3004452278
^ ^
Firm Canada Med Express
Address 330 McCowan Road Suite 1508, Scarborough, Ontario,M1J 3N3 Canada
FEI# 3004452279
^ ^
Firm Arborg Pharmacy
Address 273 Main St, Box 640, Arborg, MB R0C 0A0, Canada
FEI# 3004452283
^ ^
Firm Canamerica Drugs
Address 12 Carina Cove, Winnipeg, MB, Canada R2V 4N8
FEI# 3004452158
^ ^
Firm Canadiansdrugstore.com
Address Martin Bean, 1609-200 Ronald St., Winnipeg, MB,
Canada R3J 3J3
FEI# 3004452159
^ ^
Firm Black Mountain IDA Pharmacy (1979) Ltd.
Address 11-590 Hwy. 33 W., Kelowna, B.C. Canada V1X 6A8
FEI# 3004452167
^ ^
^ ^
Firm Canada Rx Connection
Address 11 Ayr Blvd., Winnipeg, Manitoba, Canada R3P 0K4
FEI# 3004452169
^ ^
Firm Health 2000 Pharmacy
Address 105-6950 Nicholson Rd., North Delta, BC, Canada V4E 1Z7
FEI# 3004217327
^ ^
Firm MediMart Pharmacy
Address Paul Emmer, 1511-690 Kenaston Blvd. Winnipeg,
MB, Canada R3N 1Z3
FEI# 3004452182
^ ^
Firm Access Meds
Address 46 Parnlet, Newcastle, South Africa
FEI# 3004452185
^ ^
Firm Pharmacy International
Address 61 King George, Roseau, Dominica
FEI# 3004452192
^ ^
Firm Rx2world
Address c/- monarch holdings, PO Box 257, Port Vila, Vanuatu
FEI# 3004452194
^ ^
Firm E-pharmacy.net
Address World Pharmacy Supplies, c/-Suite 9, 14 Norton St,
Leichhardt 2040, NSW Australia
FEI# 3004452204
^ ^
Firm i-pharmacy
Address PO Box w66, Shop 3, 14-16 Military Rd. Watson's Bay NSW 2030
Austrailia
FEI# 3004452208
^ ^
Firm Planet Drugs Direct Ltd.
Address PO Box 33 893 Takapuna, North Shore City, New Zealand
FEI# 3004051223
^ ^
Firm Hometown Meds
Address Robert Watts, 43 Roslyn Rd, Winnipeg, MB, Canada R3L 0G1
FEI# 3004452214
^ ^
Firm Icanrx.com
Address Contact Media Group, 12840 16th Ave #203, White Rock, BC V4A 1N6
Canada
FEI# 3004452216
^ ^
Firm CANUSA Health Group
Address Doug Burton, 865 Brawley Road West, Ashburn, Ontario,
Canada L1M 1M5
FEI# 3004452226
^ ^
Firm Good Samaritan Rx
Address Dr Morgan Campbell Inc., 124 3185 King George Hwy,
Surrey, BC, Canada V4P 2J9
FEI# 3004452228
^ ^
Firm Pharmawest Pharmacy Ltd.
Address #69-15515-24 Avenue, Surrey, BC, Canada V4A 2J4
FEI# 3004452235
^ ^
Firm Direct Drugs
Address 1569 Orange Street, Winnipeg, Manitoba, Canada R3E 3S2
FEI# 3004452238
^ ^
Firm Pelikon Investments Limited
Address Peter Kraus, Mykinon 1, Nicosia, NO 1065, Cypress
FEI# 3004452302
^ ^
Firm Canadian Pharmacy
Address See Phuket, 12 De Castro Street, Tortola
British Virgin Islands, 12345
FEI# 3004452315
^ ^
Firm 1Meds
Address Steven King, 21 Marion St., Shorewood 7276, Taiwan
FEI# 3004452316
^ ^
Firm Canada Value Meds
Address Junodis Solutions, 47 Regent Ave., Hamilton, Ontario Canada
L9B 1R4
FEI# 3004452318
^ ^
Firm Americana Meds
Address Kelsie Mercer, 319 South River Road, Elora, Ontario, Canada
NOB 1SO
FEI# 3004452156
^ ^
Firm Online-Pharmacy
Address Online Pharmacy SA, Corrientes 1820, Buenos Aires,
Capital Federal 1108, Argentina
FEI# 3004452322
^ ^
Firm Discount Prescription Drugs Online
Address Liberty Lifestyle Pty Ltd, Barry West, P.O. Box 103 Concord West
Sydney, NSW 2138 Australia
FEI# 3004452329
^ ^
Fentanyl All All
60M 24
12/06/02
Other names: Actiq
PRODUCT/PRODUCT CODE SOURCE COUNTRY
Bosentan All All
60TCA99
12/06/02
Other names: Tracleer
Clozapine All All
65V 13
12/06/02
Other names: Clopine, Clopsine, Clozaril, Elcrit, Froidir, Lanolept, Leponex,
Zolapin
Dofetilide All All
63E 32
12/06/02
Other names: Tikosyn
Alosetron Hydrochloride All All
61T 30
12/06/02
Other names: Lotronex
Mifepristone All All
65J 38
12/06/02
Other names: Mifegyne, Mifeprex
Sodium Oxybate All All
60P--01
65V 50
12/06/02
Other names: Alcover, Anetamin, Gamma-OH, Somsanit, Xyrem
Trovafloxacin All All
61H 47
12/06/02
Other names: Trovan
Thalidomide All All
65V--40
12/06/02
Other names: Synovir, Thalomid
PRODUCT SOURCE
Ancom Tablets Shanghai Pharmaceutical Industry Corp. (mfg)
GPI=VI 27 Chungshan Road
GPI=DR Shanghai, China
2/12/03 FEI # 3003884699
China National Medicines & Health (shipper)
Products Import & Export Corp.
Shanghai Branch
27 Chungshan Road (E1)
Shanghai, China
FEI # 5534
Tourasia (internet promoter)
246 Sukhumvit Soi 16
Bangkok, Thailand 10110
FEI # 3003925496
Charisma Co., Ltd. (internet promoter)
248/1 Sukhumvit Soi 16
Bangkok, Thailand 10110
FEI # 3003925501
Source Product/Product Code Country
(manufacturer) "Busto-Lift" capsules Italy
Italiani Selex and cream for growth 04/23/03
20063 Cassina de Pecchi enlargement of the
Milano, Italy Female bust
FEI # 3003901090 53LC-99
66VA-99
(shipper) 66VB-99
Luoice Marketing Enterprise
No. 7 Off Jalan Bukit Bintang
Luala Lumpur, Malaysia
FEI # 3003901091
(manufacturer) "Recovery Biostructural Canada
Biomedica Laboratories, Inc. Medicines" for relief of 4/29/03
"No Street Address" Chronic pain and
Vancouver, British Columbia, inflammation
Canada
FEI # 3003807448 54FCR99
(Shipper)
The Nutraceutical Medicine Co.
Unit #2, 3006 Boys Road
Duncan, British Columbia, Canada V9L 6W4
FEI # 3003056414
Chemon Inc. "Joint by Joint" Korea, Republic of
4645 Chung-Ri Supplement 5/5/03
Kusung-Up, Yougin-Si GPI - DR/VI
Kyungki-Do, Korea
FEI# 3003952905
Product Source: Country:
Sildenafil citrate Generic Viagra Bz Belize
(generic) 5870 Manatee Drive
65P02 Button Wood Bay, Belize
5/23/03 FEI# 3003868410
^
^
All drugs Mr. Vikan Thailand
GPI-DR Carrefour Rama 4 Road
GPI-VI MBE Suite 019
5/23/03 Bangkok, 10110, Thailand
FEI# 3003885661
^
^
Agrumax Bioxem, Inc. Canada
54AGL90 1421 Nobel
8/19/03 Sainte-Julie
Quebec, Canada
FEI# 3003756848
Face Cream Diane de Beaute All
53L[][][][]/64X[][][][] PO Box 11-7599
9/5/03 Beirut, Lebanon
FEI# 3003914273
Charantia Ampalaya Herbcare Corp. Philippines
Food Supplement Herbcare Center, PDC Compound
54E[][]99 - Tea form Pilar Village, Las Pinas City,
54F[][]99 - Capsule form Philippines
FEI# 3003865977
and
Herbcare Corp. Philippines
Box 163
Las Pinas City,
Philippines
FEI# 3003659682
Herbal Medicines including Akita Herbal Products Philippines
Gluco-Norm Gold, Corner Volga and Zambensi Streets
Banabooster, Riverside Subdivision Friendship
Cancers Protocol Angeles City, Philippines
54Y- - - FEI #3003977207
66V- - -
11/17/03
Eleotin (and all products Eastwood Bio-Medical Canada
from this firm making Research Inc.
any drug claims) #1130-4871 Shell Road
GPI = DR Richmond, B.C. V6X 3Z6
GPI = VI CANADA
61P[][]99 FEI #3001619750
54F[][]99
12/1/03
The product label indicates Eleotin is a supplement, but refers customers to
the firm's website www.eastwoodcos.com which claims the product can be used to
treat diabetes. The product can also be purchased from the firm's website.
The website claims Eleotin restores the body's own ability to control blood
glucose levels and results in long-term molecular level changes to assist the
body to recover glucose normalcy.
According to the firm's website, Eastwood Bio-Medical Research Inc. is engaged
in the development and commercialization of safe and effective treatment for
non-insulin dependent diabetes mellitus and cancer.
:
Careseng #1 Pegasus Pharmaceuticals Group Inc. Canada
(Capsules & Liquids) 3331 No. 3 Road
66V -- 99 Richmond, British Columbia
1/13/04 Canada
FEI #3004153848
Careseng #2
66V- -99 Dba
3/1/04
Pegasus Natural Supplements, Inc.
Unknown
Richmond, Canada
FEI #3003817323
Pegasus Pharmaceuticals, Inc.
#156 11786 River Rd
Richmond, Canada
FEI #3003114241
Pegasus Pharmaceut
156 11786 River Road
Richmond, Canada
FEI #3003659429
PRODUCT SOURCE COUNTRY
All Products American Style Products India
2/6/04 BHikaji Cam PL
New Delhi, IN
FEI: 3004413333
The agency received information about an overseas internet site selling counterfeit contraceptive
patches that contain no active ingredients. The counterfeit contraceptive patches were promoted
as Ortho Evra transdermal patches, Ortho Evra transdermal patches, a
Johnson and Johnson's Ortho-McNeil Pharmaceutical, Inc. product..
This internet site's domain name is www.rxpharmacy.ws .
Ukrain Nowicky Pharma Austria
2/6/04 Margaretenstrasse 7
Vienna, a-1040
FEI: 3000960791
UKRAIN is an injectable promoted as an anticancer drug. Districts encountering
shipments of this product should contact DIOP using the ORA HQ DIOP EMPLOYEES
e-mail for guidance.
PRODUCT/PRODUCT CODE SOURCE COUNTRY
All Skin Bleaching and Catherine Abbaa Nigeria
Lightening Lotions, 98 Badagry Exp. Way
Creams, Soaps and Lagos, Nigeria
Serum FEI# 3003407077
66[][][][]
53[][]-[][]
3/9/04
Note: products may be entering as skin care cosmetics, therefore, we have
included the product code "53[][]-[][]" along with the appropriate drug code.
Broncolin and Broncolin with Propolis are being promoted as dietary
supplements, however both contain undeclared drugs. Broncolin was found to
contain undeclared Guaifenesin and Tramadol HCL. Tramadol is a prescription
pain reliever. Broncolin with Propolis was found to contain Guaifenesin.
PRODUCT SOURCE COUNTRY
Broncolin, Distribudora de Alimentos Naturales Mexico
Broncolin with y Nutricionales S.A. de C.V.
Propolis Manuel Avila Camacho No. 44-A
62U- - 99 Col. Ejidos de Sta. Ma. Aztahuacan
36C- - 99 Mexico D.F., Mexico 09570
66V- - 99 FEI# 3002779991
3/12/04
Distribudora de Alimentos Naturales Mexico
Y Nutricionales S.A. de C.V.
Oriente 152 No. 287, Colonia Moctezuma
2da Seccion
Mexico D.F., Mexico
FEI# 1000464180
PRODUCT/PRODUCT CODE SOURCE COUNTRY
Humatrope ALL ALL
64R[][]23
3/26/04
Other names: Somatropin, biosynthetic; Growth Hormone Recombinan
Plenaxis ALL ALL
60V[][]99
3/26/04
Other names: Abarelix
PRODUCT SOURCE COUNTRY
Plaquex All All
3/26/04
A product used for chelation therapy is represented to be useful in a number
of therapeutic conditions. It is called Plaquex. The product comes into the
country from the Bahamas using the personal importation policy on the "front"
end, however a recently detained package eclared the contents to be a
nutritional supplement. The company involved in this is called Jeunomed
International and it has a Key Biscayne address. Product administration is by
IV and requires refrigeration. One 50ml vial is said to contain 2500ml
essential Phospholipids as 70% Phosphatidylcholine, 1250mg Deoxycholic acid,
10mg Vitamin E, 10mg Nicotinic acid, 10mg Adenosine triphosphate, 450mg Benzyl
alchohol and 120mg Ethanol. Plaquex, is an injectable drug product, and as
such, it poses a significant health risk and it is being promoted in the U.S.
through the internet ; e.g. http://www.plaquex.ch/.
PRODUCT SOURCE COUNTRY
V-1, V-4 Magnesium Jirashataporn Co., Ltd. Thailand
Dietary Supplements 72/2-3 Moo 10 Sukumvit Rd.
GPI=DR Chachoengsao, Thailand
54Y- -99 FEI# 3004375809
54B- -08
4/15/04 Immunitor Manufacturer Co., Ltd. Thailand
71 Moo 5,Bangpakong Industrial Park
Chachoengsao, Thailand 24130
FEI# 3004375808
Avicenna Pharma brand A.M. Herbs(M) SDN BHD Malaysia
Dietary supplements: 2-4 Jalan 3/114,
Cholestmed Kuchai Business Center
Glucosure 58200 Kuala Lumpur
Gastro Balance Malaysia
Renalife FEI# 3004686954
Livtone
Respire
Product Codes: 54Y--99 54F--99
9/1/04
PRODUCT SOURCES COUNTRY
Sildenafil Citrate Vee Excel Drugs & India
Tablets Pharmaceuticals (P) Ltd
65P02 G-16, 3rd Floor
9/16/04 Preet Vihar, Vikas Marg
Delhi, India
FEI# 3004062123
Vee Excel (V Excel International)
2, Veer Sawarkar Block
Triveni Complex
Madhuban Road, Shakar Pur
Delhi, India
FEI# 3003945550
Vee Excel Drugs & Pharmaceutical
R-23-B, 1/F, Rita Block
Delhi, India
FEI# 3004062373
PRODUCT SOURCES COUNTRY
Wings Heartdrop Formula Wings International CANADA
Herbal Tinture Marketing Ltd.
54F[][]99 6595 Herry Road.
9/30/04 Vernon, BC
Canada
FEI #3004497001
PRODUCT SOURCES COUNTRY
"Actra-RX" Shenyang Changgong Yibao Alcohol Co. Ltd. All
Other names: "Yilishen" Under the supervision of
54- - - - Shenyand Medicline Research on Biologic Resource
65P- - -02 126 Changbai Street, Dongling District
(Contains prescription strength Shengyang, Liaoning, China
sildenafil by FDA analysis) FEI: 3003791634
11/10/04