Import Alert 60-01
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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 # 60-01
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Tagamet Tablets Cimetidine Tablets (Canada)"
Reason for Alert:
Minneapolis and Detroit districts recently reported activity in the importation of Canadian Tagamet. Detroit district refused entry of a shipment of Canadian Tagamet which was consigned to Crosstown Drug, Hamlake, Minnesota.
We were previously aware that shipments had entered through Portland, Oregon and Murfreesboro, Tennessee, while Buffalo, Boston, and Nashville districts had previously detained attempted entries. There is reason to believe that there may be attempts to enter Canadian Tagamet through other U.S. ports of entry as well.
Smith, Kline & French Laboratories (USA) is concerned about such illegal importations and they are making every effort to stop them. Smith, Kline & French, Canada Ltd., has not been implicated in the illegal importation. Two shippers that have been identified, Speedway Drugs, Edmonton, Alberta, Canada, and National Drug Ltd., Winnipeg, Manitoba, Canada, (shipper of product to Crosstown Drug) are wholesalers who do not purchase directly from the manufacturer, but from other wholesalers.
Tagamet manufactured in Canada, is considered a new drug which may only be imported/marketed in this country pursuant to an approved new drug application (NDA). No such approval has been granted, nor is any application for approval on file for the Canadian facility.
The unapproved product is produced by:
Smith, Kline & French, Canada Ltd.
1940 Argentina Road
Mississauga (Toronto) Ontario
The identifying features of the package are:
1) Generally packed in bottles of 1000 tablets:
2) The name of the manufacturer, Smith, Kline & French, Canada Ltd., and directions for use appear on the label in English and French;
3) The label fails to bear a NDC number, nor is there an insert attached to the package:
4) The label bears a number required by the Canadian Government, known as a DIN number, which for Tagamet 300 mg tablet is DIN #397474:
5) Tagamet (Canadian) is the same color, size, and shape as the American version, but the tablet markings are different as follows:
American Tagamet Canadian Tagamet
Tagamet 300 SKF
SKF T13
Tagamet 200 SKF
SKF T12
While we have no information that there is any effort to import generic cimetidine manufactured in Canada, you should be aware that there are three Canadian manufacturers for the generic drug product, two of which have the same light green color as the American product. However, because of significant price differential, an attempt may be made to import the generic product. We therefore, include the following information for your records.
Available
Manufacturer Product Name Strength Tablet Markings
All strengths light
green color
Apotex, Inc. APO Cimetidine 300 mg Marked APO 300
406 Ormont Dr. Tablet 200 mg Marked APO 200
All strengths light
green color
NovoPharm Nova Cimetidine 300 mg Marked NOVO 300
1290 Ellsmere Tablet 200 mg Marked NOVO 200
Rd. Scarborough
Toronto, Canada
Horner Labs Ltd. Pettol Tablet 300 mg 300 mg blue color
5485 Ferrier St. Marked 300 FWH
Montreal, Canada
200 mg 200 mg yellow color
Marked FWH 200
We were previously aware that shipments had entered through Portland, Oregon and Murfreesboro, Tennessee, while Buffalo, Boston, and Nashville districts had previously detained attempted entries. There is reason to believe that there may be attempts to enter Canadian Tagamet through other U.S. ports of entry as well.
Smith, Kline & French Laboratories (USA) is concerned about such illegal importations and they are making every effort to stop them. Smith, Kline & French, Canada Ltd., has not been implicated in the illegal importation. Two shippers that have been identified, Speedway Drugs, Edmonton, Alberta, Canada, and National Drug Ltd., Winnipeg, Manitoba, Canada, (shipper of product to Crosstown Drug) are wholesalers who do not purchase directly from the manufacturer, but from other wholesalers.
Tagamet manufactured in Canada, is considered a new drug which may only be imported/marketed in this country pursuant to an approved new drug application (NDA). No such approval has been granted, nor is any application for approval on file for the Canadian facility.
The unapproved product is produced by:
Smith, Kline & French, Canada Ltd.
1940 Argentina Road
Mississauga (Toronto) Ontario
The identifying features of the package are:
1) Generally packed in bottles of 1000 tablets:
2) The name of the manufacturer, Smith, Kline & French, Canada Ltd., and directions for use appear on the label in English and French;
3) The label fails to bear a NDC number, nor is there an insert attached to the package:
4) The label bears a number required by the Canadian Government, known as a DIN number, which for Tagamet 300 mg tablet is DIN #397474:
5) Tagamet (Canadian) is the same color, size, and shape as the American version, but the tablet markings are different as follows:
American Tagamet Canadian Tagamet
Tagamet 300 SKF
SKF T13
Tagamet 200 SKF
SKF T12
While we have no information that there is any effort to import generic cimetidine manufactured in Canada, you should be aware that there are three Canadian manufacturers for the generic drug product, two of which have the same light green color as the American product. However, because of significant price differential, an attempt may be made to import the generic product. We therefore, include the following information for your records.
Available
Manufacturer Product Name Strength Tablet Markings
All strengths light
green color
Apotex, Inc. APO Cimetidine 300 mg Marked APO 300
406 Ormont Dr. Tablet 200 mg Marked APO 200
All strengths light
green color
NovoPharm Nova Cimetidine 300 mg Marked NOVO 300
1290 Ellsmere Tablet 200 mg Marked NOVO 200
Rd. Scarborough
Toronto, Canada
Horner Labs Ltd. Pettol Tablet 300 mg 300 mg blue color
5485 Ferrier St. Marked 300 FWH
Montreal, Canada
200 mg 200 mg yellow color
Marked FWH 200
Guidance:
Increased surveillance is indicated for SKF's Tagamet Tablets (all strengths) and Cimetidine Tablets (all strengths) produced in Canada.
Product Description:
Cimetidine (Tagamet) tablets
Charge:
"The article is violative within the meaning of section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new drug without an approved new drug application (NDA) pursuant to section 505."
OASIS charge code - UNAPPROVED
OASIS charge code - UNAPPROVED
CANADA
Apotex Inc.
Date Published : 09/10/2009
150 Signet Drive , Toronto, Ontario CANADA
60 T - - 05 Cimetidine (Antagonist)
Date Published: 09/10/2009
Horner, Frank L. Inc.
Date Published : 09/10/2009
5485 Ferrier St. , Montreal, QC CANADA
60 T - - 05 Cimetidine (Antagonist)
Date Published: 09/10/2009
Novopharm Limited
Date Published : 09/10/2009
30 Nably Court , Scarborough, ON CANADA
60 T - - 05 Cimetidine (Antagonist)
Date Published: 09/10/2009
Smith Kline & French Canada Ltd
Date Published : 09/10/2009
1940 Argentina Rd , Mississauga, ON CANADA
60 T - - 05 Cimetidine (Antagonist)
Date Published: 09/10/2009
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