Drug Recall Listings - Recall Posting Date

(From July 2010 - September 2010)

Recall Posting Date

2010-09-27

Trade Name

EOD (Erection On Demand)

Recalling Firm

Kaytel Video
2150 Ward Street,
Saint-Laurent, Quebec
H4M 1T7

Recall Start Date

2010-09-02

DIN, NPN, DIN-HM

No MA

Hazard Classification

Type I

Dosage Form

Capsule

Strength

N/A

Lot Number

(L) 4332

Marketing Authorization Holder

N/A

Reason for Recall

Herbal product adulterated with Tadalafil (between 6 and 18 mg Tadalafil /capsule)

Depth of Recall - Distribution

Product sold nationally in Sex shops and Video XXX.

Recall Posting Date

2010-09-13

Trade Name

Apo-Clonidine Tab
(Ammended Distribution)

Recalling Firm

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2010-07-12

DIN, NPN, DIN-HM

DIN 00868949

Hazard Classification

Type II

Dosage Form

Tablet

Strength

0.1 mg

Lot Number

JE8889

Marketing Authorization Holder

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Out of specification for dissolution at 6 month timepoint.

Depth of Recall - Distribution

Canada (eg. Wholsalers, pharmacies, etc)
Bahamas, Barbados, Bermuda, Cayman Islands, Haiti, Saint Lucia, Saudi Arabia, United Arab Emirates

Recall Posting Date

2010-09-13

Trade Name

Apo-Clonidine Tab
(Ammended Distribution)

Recalling Firm

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2010-07-12

DIN, NPN, DIN-HM

DIN 00868957

Hazard Classification

Type II

Dosage Form

Tablet

Strength

0.2 mg

Lot Number

JA8365, JA8366

Marketing Authorization Holder

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Out of specification for dissolution at 6 month timepoint.

Depth of Recall - Distribution

Canada (eg. Wholsalers, pharmacies, etc)
Bahamas, Barbados, Bermuda, Cayman Islands, Haiti, Saint Lucia, Saudi Arabia, United Arab Emirates

Recall Posting Date

2010-09-13

Trade Name

Apo-Clonidine Tab
(Ammended Distribution)

Recalling Firm

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2010-07-12

DIN, NPN, DIN-HM

DIN 02248732

Hazard Classification

Type II

Dosage Form

Tablet

Strength

0.025 mg

Lot Number

JE8873, JD1167

Marketing Authorization Holder

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Out of specification for dissolution at 6 month timepoint.

Depth of Recall - Distribution

Canada (eg. Wholsalers, pharmacies, etc)
Bahamas, Barbados, Bermuda, Cayman Islands, Haiti, Saint Lucia, Saudi Arabia, United Arab Emirates

Recall Posting Date

2010-09-13

Trade Name

Co Atorvastatin

Recalling Firm

Cobalt Pharmaceuticals Inc.
6500 Kitimat Road,
Mississauga, Ontario
L5N 2B8

Recall Start Date

2010-08-20

DIN, NPN, DIN-HM

DIN 02310910

Hazard Classification

Type III

Dosage Form

Tablet

Strength

40 mg

Lot Number

0798020
0814020
0834020

Marketing Authorization Holder

Cobalt Pharmaceuticals Inc.
6500 Kitimat Road,
Mississauga, Ontario
L5N 2B8

Reason for Recall

Uncharacteristic odour believed to be linked to tribromoanisol in the noted lots which were supplied by Pfizer and associated with their recent recall.

Depth of Recall - Distribution

Distributed across Canada to various distributor, wholesale, and retail (eg. pharmacies, hospitals, etc) level customers. Two exports to the USA (Amerisourcebergen; New Jersey and Kansas).

Recall Posting Date

2010-09-13

Trade Name

Glucagen Hypokit

Recalling Firm

Novo Nordisk Canada Inc.
300-2680 Skymark Avenue,
Mississauga, Ontario
L4W 5L6

Recall Start Date

2010-08-19

DIN, NPN, DIN-HM

DIN 02333627

Hazard Classification

Type II

Dosage Form

Kit, Powder for Solution

Strength

1 mg/vial

Lot Number

YW60335
YW60351

Marketing Authorization Holder

Novo Nordisk Canada Inc.
300-2680 Skymark Avenue,
Mississauga, Ontario
L4W 5L6

Reason for Recall

This recall is being initiated as a result of a quality issue that NNCI discovered on GlucaGen© Hypokit on the market. The quality issue is the identification of cracks in a few of the water for injection syringes (WFI-syringes packed in GlucaGen© Hypokit). Based on NNCI?s inspection data, it is estimated that a maximum of 0.03 % of the syringes may have this defect. There are no reported adverse reaction reports or customer complaints related to this lot.

Depth of Recall - Distribution

Sold and distributed to wholesalers and pharmacies in Canada only.

Recall Posting Date

2010-09-13

Trade Name

Neem Active Toothpaste - Complete Care

Recalling Firm

Quality Natural Foods Ltd.
91 Select Ave.
Toronto, Ontario
M1V 4A8

Recall Start Date

2010-08-17

DIN, NPN, DIN-HM

No MA

Hazard Classification

Type III

Dosage Form

Paste

Strength

1000 ppm of fluoride

Lot Number

125 g tubes (100g + 25g bonus)
Batch #:W035
Batch #: W039

200 g tubes
Batch #: 01
Batch #: 06

Marketing Authorization Holder

N/A

Reason for Recall

Product is not licensed for sale in Canada.

Depth of Recall - Distribution

Product was distributed in Ontario, British Columbia, Manitoba, Saskatoon, and Alberta.
Product was not exported by Quality Natural Foods Ltd.

Recall Posting Date

2010-09-13

Trade Name

Praxair - liquid Oxygen

Recalling Firm

Praxair Canada Inc.
1050, 7th Avenue North,
Hanover, Ontario
N4N 2K1

Recall Start Date

2010-07-30

DIN, NPN, DIN-HM

N/A

Hazard Classification

Type III

Dosage Form

Gas

Strength

N/A

Lot Number

N/A

Marketing Authorization Holder

N/A

Reason for Recall

Driver picked up commercial grade O2 for filling at curbside rather than the USP grade.

Depth of Recall - Distribution

Distributed directly to three customers for home care O2 .

Recall Posting Date

2010-09-13

Trade Name

Scopolamine Hydrobromide Injection

Recalling Firm

Omega Laboratories Ltd.
11177 Hamon
Montreal, Quebec
H3M 3E4

Recall Start Date

2010-08-19

DIN, NPN, DIN-HM

DIN 02242810

Hazard Classification

Type II

Dosage Form

Solution

Strength

0.4 mg/mL

Lot Number

9K184
0D350

Marketing Authorization Holder

Omega Laboratories Ltd.
11177 Hamon
Montreal, Quebec
H3M 3E4

Reason for Recall

Lot 9K184 is being recalled for an out-of-specification stability result at the 9 month interval. The out-of-specification result is due to a concentration of the active ingredient that is currently lower than the accepted specification (0.35 mg/mL vs 0.36-0.44 mg/mL). In addition, as a precautionary measures only, the lot 0D350 is being recalled since the concentration of the active ingredient showed a downward trend in the stability study.

Depth of Recall - Distribution

Wholesalers and hospitals in Canada only.

Recall Posting Date

2010-09-13

Trade Name

Scopolamine Hydrobromide Injection

Recalling Firm

Omega Laboratories Ltd.
11177 Hamon
Montreal, Quebec
H3M 3E4

Recall Start Date

2010-08-19

DIN, NPN, DIN-HM

DIN 02242811

Hazard Classification

Type II

Dosage Form

Solution

Strength

0.6 mg/mL

Lot Number

9K202
0F390

Marketing Authorization Holder

Omega Laboratories Ltd.
11177 Hamon
Montreal, Quebec
H3M 3E4

Reason for Recall

Lots 9K202 and 0F390 are being recalled as a precautionary measures only since the concentration of the active ingredient showed a downward trend in the stability study.

Depth of Recall - Distribution

Wholesalers and hospitals in Canada only.

Recall Posting Date

2010-09-13

Trade Name

SX Male Enhancement

Recalling Firm

Coast to Coast Video Ltd.
400-110 Cambie Street,
Vancouver, British Columbia
V6B 2M8

Recall Start Date

2010-08-03

DIN, NPN, DIN-HM

No MA

Hazard Classification

Type I

Dosage Form

Capsule

Strength

Ciwujia Extract (100mg)
Ginseng Extract (30mg)
Chinese Wolf-berry Extract (25mg)
Lycium Fruit Extract (10mg)
Poria (Wolfipoia cocos) Extract (15mg)

undeclared active ingredient:
acetildenafil (99.8mg)

Lot Number

N/A

Marketing Authorization Holder

N/A

Reason for Recall

SX Male Enhancement promoted as a herbal supplement, found to contain 99.8 mg/capsule of undeclared actildenafil, an analogue of Sildenafil, a prescription drug. The product is not authorized for sale in Canada.

Depth of Recall - Distribution

Distributed nationally to retail stores. No known export.

Recall Posting Date

2010-08-30

Trade Name

Chemspec DFC Sodium Hypochlorite disinfectant/disinfectant cleaner

Recalling Firm

Chemical Specialities Manufacturing Corp
901 North Newkirk Street
Baltimore, Maryland,
USA 21205

Recall Start Date

2010-08-11

DIN, NPN, DIN-HM

DIN 02327686

Hazard Classification

Type III

Dosage Form

Liquid

Strength

1.4% w/w

Lot Number

A040110

Marketing Authorization Holder

Chemical Specialties Manufacturing Corp
200 Confederation Parkway
Concord, Ontario,
Canada L4K 4T8

Reason for Recall

The lot number A040110 may contain sodium hypochlorite concentrations outside of the specification dictated by the monograph.

Depth of Recall - Distribution

All Health Canada DIN registered product is distributed and consumed in Canada. End uses include hospitals, long-term care and rehab facilities.

Recall Posting Date

2010-08-30

Trade Name

Gambrosol Trio 40G 20C

Recalling Firm

Gambro Canada
2 East Beaver Creek Road, Unit 4
Richmond Hill, Ontario
L4B 2N3

Recall Start Date

2010-07-28

DIN, NPN, DIN-HM

DIN 02246720

Hazard Classification

Type III

Dosage Form

Intraperitoneal solution

Strength

40 g

Lot Number

695241

Marketing Authorization Holder

Gambro Canada
2 East Beaver Creek Road, Unit 4
Richmond Hill, Ontario
L4B 2N3

Reason for Recall

Gambro has become aware of a potential slight deviation from the specifications for the glucose concentration in a single batch (695241) of the product. A slightly low concentration of glucose was detected in the product.

Depth of Recall - Distribution

Ontario, Alberta and Quebec. No export.

Recall Posting Date

2010-08-30

Trade Name

SeXXX Drive

Recalling Firm

Lockerroom Marketing Ltd.
694 Derwent Way,
Delta, British Columbia
V3M 5P8

Recall Start Date

2010-07-22

DIN, NPN, DIN-HM

No MA

Hazard Classification

Type I

Dosage Form

Capsule

Strength

Cordyceps sinensis (80mg)
Panax ginseng (80mg)
Epimedium brevicornum (60mg)
Morinda officinalis (60mg)
Eucommia ulmoides (40mg) Ginkgo Biloba (40mg)

undeclared active ingredient:
hydroxyhomosildenafil

Lot Number

N/A

Marketing Authorization Holder

N/A

Reason for Recall

SeXXX Drive promoted as a herbal supplement, found to contain 89.9 mg/capsule of undeclared hydroxyhomosildenafil, an analogue of Sildenafil, a Schedule F drug. The product is not authorized for sale in Canada.

Depth of Recall - Distribution

Distributed nationally to retail stores and the distributor AJP Enterprises doing business as IT Erotics. No known export.

Recall Posting Date

2010-08-30

Trade Name

SeXXX Drive

Recalling Firm

AJP Enterprises dba IT Erotics
694 Derwent Way,
Delta, British Columbia
V3M 5P8

Recall Start Date

2010-07-22

DIN, NPN, DIN-HM

No MA

Hazard Classification

Type I

Dosage Form

Capsule

Strength

Cordyceps sinensis (80mg)
Panax ginseng (80mg)
Epimedium brevicornum (60mg)
Morinda officinalis (60mg)
Eucommia ulmoides (40mg) Ginkgo Biloba (40mg)

undeclared active ingredient:
hydroxyhomosildenafil

Lot Number

N/A

Marketing Authorization Holder

N/A

Reason for Recall

SeXXX Drive promoted as a herbal supplement, found to contain 89.9 mg/capsule of undeclared hydroxyhomosildenafil, an analogue of Sildenafil, a Schedule F drug. The product is not authorized for sale in Canada.

Depth of Recall - Distribution

Distributed nationally to retail stores. No known export.

Recall Posting Date

2010-08-30

Trade Name

SeXXX Drive

Recalling Firm

Coast to Coast Video Ltd. (dba Fantasy Factory)
400-110 Cambie Street,
Vancouver, British Columbia
V6B 2M8

Recall Start Date

2010-08-03

DIN, NPN, DIN-HM

No MA

Hazard Classification

Type I

Dosage Form

Capsule

Strength

Cordyceps sinensis (80mg)
Panax ginseng (80mg)
Epimedium brevicornum (60mg)
Morinda officinalis (60mg)
Eucommia ulmoides (40mg) Ginkgo Biloba (40mg)

undeclared active ingredient:
hydroxyhomosildenafil

Lot Number

N/A

Marketing Authorization Holder

N/A

Reason for Recall

SeXXX Drive promoted as a herbal supplement, found to contain 89.9 mg/capsule of undeclared hydroxyhomosildenafil, an analogue of Sildenafil, a Schedule F drug. The product is not authorized for sale in Canada.

Depth of Recall - Distribution

Distributed nationally to retail stores. No known export.

Recall Posting Date

2010-08-20

Trade Name

Apo-Azathioprine Tab

Recalling Firm

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2010-07-12

DIN, NPN, DIN-HM

DIN 02242907

Hazard Classification

Type II

Dosage Form

Tablet

Strength

50 mg

Lot Number

JC6979

Marketing Authorization Holder

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Potential foreign matter contamination (metallic particles).

Depth of Recall - Distribution

Canadian customers only (eg. Wholesalers, pharmacies, etc), no export.

Recall Posting Date

2010-08-20

Trade Name

Apo-Clonidine Tab

Recalling Firm

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2010-07-12

DIN, NPN, DIN-HM

DIN 00868949

Hazard Classification

Type II

Dosage Form

Tablet

Strength

0.1 mg

Lot Number

JE8889

Marketing Authorization Holder

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Out of specification for dissolution at 6 month timepoint.

Depth of Recall - Distribution

Canadian customers only (eg. Wholesalers, pharmacies, etc), no export.

Recall Posting Date

2010-08-20

Trade Name

Apo-Clonidine Tab

Recalling Firm

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2010-07-12

DIN, NPN, DIN-HM

DIN 00868957

Hazard Classification

Type II

Dosage Form

Tablet

Strength

0.2 mg

Lot Number

JA8365 & JA8366

Marketing Authorization Holder

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Out of specification for dissolution at 6 month timepoint.

Depth of Recall - Distribution

Canadian customers only (eg. Wholesalers, pharmacies, etc), no export.

Recall Posting Date

2010-08-20

Trade Name

Apo-Clonidine Tab

Recalling Firm

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2010-07-12

DIN, NPN, DIN-HM

DIN 02248732

Hazard Classification

Type II

Dosage Form

Tablet

Strength

0.025 mg

Lot Number

JE8873 & JD1167

Marketing Authorization Holder

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Out of specification for dissolution at 6 month timepoint.

Depth of Recall - Distribution

Canadian customers only (eg. Wholesalers, pharmacies, etc), no export.

Recall Posting Date

2010-08-20

Trade Name

Apo-Naproxen Tab

Recalling Firm

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2010-07-12

DIN, NPN, DIN-HM

DIN 00592277

Hazard Classification

Type II

Dosage Form

Tablet

Strength

500 mg

Lot Number

HY8172 & HY8179

Marketing Authorization Holder

Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Possible foreign matter contamination (eg, plastic material (polypropylene and polyester) and cellulose based fibres).

Depth of Recall - Distribution

Canadian customers only (eg. Wholesalers, pharmacies, etc), no export.

Recall Posting Date

2010-08-20

Trade Name

Lipitor

Recalling Firm

Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5

Recall Start Date

2010-08-18

DIN, NPN, DIN-HM

DIN 02230714

Hazard Classification

Type III

Dosage Form

Tablet

Strength

40 mg

Lot Number

0779010
0780010

Marketing Authorization Holder

Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5

Reason for Recall

Uncharacteristic odour linked to 2,4,6 tribromoanisol in the lot of bottles used for the packaging of the affected product.

Depth of Recall - Distribution

Wholesalers, pharmacies and hospitals in Canada only.

Recall Posting Date

2010-08-20

Trade Name

RestoraLax 30 Once-Daily Doses

Recalling Firm

Merck/Schering Plough
16750 Trans Canada Highway,
Kirkland, Quebec
H9H 4M7

Recall Start Date

2010-07-14

DIN, NPN, DIN-HM

DIN 02318164

Hazard Classification

Type III

Dosage Form

Powder

Strength

100% w/w / 100 % p/p

Lot Number

E-MLX-64

Marketing Authorization Holder

Merck/Schering Plough
16750 Trans Canada Highway,
Kirkland, Quebec
H9H 4M7

Reason for Recall

Potential risk for defective cap liners generated during the packaging process.

Depth of Recall - Distribution

National Distribution ( drugstores and Costco). The product is not exported.

Recall Posting Date

2010-08-20

Trade Name

SX Male Enhancement Herbal Supplement

Recalling Firm

AJP Enterprises (DBA IT Erotics)
706 Derwent Way,
Delta, British Columbia
V3M 5P8

Recall Start Date

2010-07-22

DIN, NPN, DIN-HM

No NPN

Hazard Classification

Type I

Dosage Form

Capsule

Strength

99.8 mg of acetildenafil / capsule

Lot Number

N/A

Marketing Authorization Holder

N/A

Reason for Recall

SX Male Enhancement promoted as a herbal supplement, found to contain high levels of undeclared acetildenafil, a substance similar to prescription medication sildenafil. The product is not authorized for sale in Canada.

Depth of Recall - Distribution

Distributed nationally to retail stores. No known export.

Recall Posting Date

2010-08-20

Trade Name

Vinexpert Radiance Day Cream SPF10

Recalling Firm

Jean-Coutu Group
530 Beriault Street
Longueuil, Quebec
J4G 1S8

Recall Start Date

2010-07-22

DIN, NPN, DIN-HM

No DIN

Hazard Classification

Type III

Dosage Form

Cream

Strength

Avobenzone 1,75 %
Octinoxate 6,78 %
Actisalate 5,0%
Octocrylene 1,50%

Lot Number

All lots

Marketing Authorization Holder

N/A

Reason for Recall

Products have no Drug Identification Number (DIN) . Importer does not have a Establishment license to import these products.

Depth of Recall - Distribution

Jean-Coutu pharmacies -No Export

Recall Posting Date

2010-08-20

Trade Name

Vinexpert Radiance Day Fluid SFP10

Recalling Firm

Jean-Coutu Group
530 Beriault Street
Longueuil, Quebec
J4G 1S8

Recall Start Date

2010-07-22

DIN, NPN, DIN-HM

No DIN

Hazard Classification

Type III

Dosage Form

Cream

Strength

Avobenzone 1,75 %
Octinoxate 6,8 %
Actisalate 5,0 %
Octocrylene 1,5 %

Lot Number

All lots

Marketing Authorization Holder

N/A

Reason for Recall

Products have no Drug Identification Number (DIN) . Importer does not have a Establishment license to import these products.

Depth of Recall - Distribution

Jean-Coutu pharmacies -No Export

Recall Posting Date

2010-08-20

Trade Name

Vinoperfect Day Perfecting Cream SPF15

Recalling Firm

Jean-Coutu Group
530 Beriault Street
Longueuil, Quebec
J4G 1S8

Recall Start Date

2010-07-22

DIN, NPN, DIN-HM

No DIN

Hazard Classification

Type III

Dosage Form

Cream

Strength

Avobenzone 3,0 %
Octinoxate 7,5 %
Actisalate 2,0 %
Octocrylene 10,0%

Lot Number

All lots

Marketing Authorization Holder

N/A

Reason for Recall

Products have no Drug Identification Number (DIN) . Importer does not have a Establishment license to import these products.

Depth of Recall - Distribution

Jean-Coutu pharmacies -No Export

Recall Posting Date

2010-08-02

Trade Name

Clonidine HCL Tab 0.2 mg

Recalling Firm

Pro-Doc Ltd.
2925 Industrial Blvd.,
Laval, Quebec
H7L 2W9

Recall Start Date

2010-07-14

DIN, NPN, DIN-HM

DIN 01908162

Hazard Classification

Type II

Dosage Form

Tablet

Strength

0.2 mg

Lot Number

3635
3635-1

Marketing Authorization Holder

Pro-Doc Ltd.
2925 Industrial Blvd.,
Laval, Quebec
H7L 2W9

Reason for Recall

The product is being recalled due to product stability testing identifying dissolution levels that exceed specifications.

Depth of Recall - Distribution

Wholesalers only.

Recall Posting Date

2010-08-02

Trade Name

Echinacea & Goldenseal (Alcohol Free) 50 ml

Recalling Firm

Swiss Herbal Remedies Limited (Packager)
35 Fulton Way
Richmond Hill, Ontario
L4B 2N4

Recall Start Date

2010-07-05

DIN, NPN, DIN-HM

No NPN

Hazard Classification

Type II

Dosage Form

Liquid

Strength

50 ml

Lot Number

Echinacea & Goldenseal (Alcohol Free) 50 ml
Lot 34974 & 35997

Marketing Authorization Holder

N/A

Reason for Recall

Consumer complaint reported to Swiss Herbal Remedies indicated solid particles and bad smell in the product "Echinacea & Goldenseal (alcohol free) 50mL". Testing conducted by the company revealed the presence of yeast and mould in the product. Further investigation revealed products Echinacea Extract (alcohol free) 50mL, Triple Blend Echinacea (Alcohol Free) 50mL and Echinacea Kid's (alcohol Free) 50mL manufactured using same bulk material may also been affected.

Depth of Recall - Distribution

Retailers - National (Alberta, British Columbia, Ontario, New Brunswick, Nova Scotia, Quebec, Saskatchewan, Manitoba, Newfoundland/Labrador, Prince Edward Island). Exports - None.

Recall Posting Date

2010-08-02

Trade Name

Echinacea Extract (Alcohol Free) 50 ml

Recalling Firm

Swiss Herbal Remedies Limited (Packager)
35 Fulton Way
Richmond Hill, Ontario
L4B 2N4

Recall Start Date

2010-07-05

DIN, NPN, DIN-HM

No NPN

Hazard Classification

Type II

Dosage Form

Liquid

Strength

50 ml

Lot Number

Echinacea Extract (Alcohol Free) 50 ml
Lot 35720 & 35996

Marketing Authorization Holder

N/A

Reason for Recall

Consumer complaint reported to Swiss Herbal Remedies indicated solid particles and bad smell in the product "Echinacea & Goldenseal (alcohol free) 50mL". Testing conducted by the company revealed the presence of yeast and mould in the product. Further investigation revealed products Echinacea Extract (alcohol free) 50mL, Triple Blend Echinacea (Alcohol Free) 50mL and Echinacea Kid's (alcohol Free) 50mL manufactured using same bulk material may also been affected.

Depth of Recall - Distribution

Retailers - National (Alberta, British Columbia, Ontario, New Brunswick, Nova Scotia, Quebec, Saskatchewan, Manitoba, Newfoundland/Labrador, Prince Edward Island). Exports - None.

Recall Posting Date

2010-08-02

Trade Name

Echinacea Kid?s (Alcohol Free) 50 ml

Recalling Firm

Swiss Herbal Remedies Limited (Packager)
35 Fulton Way
Richmond Hill, Ontario
L4B 2N4

Recall Start Date

2010-07-05

DIN, NPN, DIN-HM

NPN 80015556

Hazard Classification

Type II

Dosage Form

Liquid

Strength

50 ml

Lot Number

Echinacea Kid?s (Alcohol Free) 50 ml
Lot 35998

Marketing Authorization Holder

Swiss Herbal Remedies Limited (Packager)
35 Fulton Way
Richmond Hill, Ontario
L4B 2N4

Reason for Recall

Consumer complaint reported to Swiss Herbal Remedies indicated solid particles and bad smell in the product "Echinacea & Goldenseal (alcohol free) 50mL". Testing conducted by the company revealed the presence of yeast and mould in the product. Further investigation revealed products Echinacea Extract (alcohol free) 50mL, Triple Blend Echinacea (Alcohol Free) 50mL and Echinacea Kid's (alcohol Free) 50mL manufactured using same bulk material may also been affected.

Depth of Recall - Distribution

Retailers - National (Alberta, British Columbia, Ontario, New Brunswick, Nova Scotia, Quebec, Saskatchewan, Manitoba, Newfoundland/Labrador, Prince Edward Island). Exports - None.

Recall Posting Date

2010-08-02

Trade Name

Emo-Cort 1% Lotion 60mL

Recalling Firm

GlaxoSmithKline Canada Inc.
7333 Mississauga Road North,
Mississauga, Ontario
L5N 6L4

Recall Start Date

2010-07-15

DIN, NPN, DIN-HM

DIN 00192600

Hazard Classification

Type II

Dosage Form

Lotion

Strength

1%

Lot Number

12R7

Marketing Authorization Holder

GlaxoSmithKline Canada Inc.
7333 Mississauga Road North,
Mississauga, Ontario
L5N 6L4

Reason for Recall

GlaxoSmithKline (GSK) received 13 complaints for Emo-Cort 1% lotion Lot 12R7, all reporting a green substance found in the product. GSK?s investigation team confirmed that the green substance was mould contamination. The species and confirmation of the type of mould has not been completed and results are expected within 2 weeks. The root cause of the mold contamination is under investigation.

Depth of Recall - Distribution

Sold and distributed to Wholesalers in Canada only. No Export.

Recall Posting Date

2010-08-02

Trade Name

Golden Lily Tao Chih Pien (For Babies)

Recalling Firm

Topwin Trading Co. Ltd.
110-2700 Olafsen Avenue
Richmond, British Columbia
V6X 2R3

Recall Start Date

2010-06-17

DIN, NPN, DIN-HM

No NPN

Hazard Classification

Type III

Dosage Form

Herbal Tablets

Strength

0.3g

Lot Number

N/A

Marketing Authorization Holder

N/A

Reason for Recall

1) Natural Health Product lacks NPN/PLA, hence is not authorized for sale in the Canadian marketplace. Violation of Section 4 of the Natural Health Product Regulations.
2) Labelling violations of product - no Canadian contact on inner / outer labels

Depth of Recall - Distribution

Distributed to retail outlets in Canada (nationwide). No exports.

Recall Posting Date

2010-08-02

Trade Name

Jamp-Ramipril

Recalling Firm

Jamp Pharma Corporation
1380-203 Newton, suite #3
Boucherville, Quebec
J4B 5H2

Recall Start Date

2010-07-12

DIN, NPN, DIN-HM

DIN 02331101

Hazard Classification

Type II

Dosage Form

Capsules

Strength

1.25 mg

Lot Number

2086918R

Marketing Authorization Holder

Jamp Pharma Corporation
1380-203 Newton, suite #3
Boucherville, Quebec
J4B 5H2

Reason for Recall

The product is being recalled because of microbiological contamination (Isolation and identification of Aeromonas hydrophila / caviae).

Depth of Recall - Distribution

Wholesalers and pharmacies. No export.

Recall Posting Date

2010-08-02

Trade Name

Naproxen - 500

Recalling Firm

Pro-Doc Ltd.
2925 Industrial Blvd.,
Laval, Quebec
H7L 2W9

Recall Start Date

2010-07-14

DIN, NPN, DIN-HM

DIN 00618721

Hazard Classification

Type II

Dosage Form

Tablet

Strength

500 mg

Lot Number

3352

Marketing Authorization Holder

Pro-Doc Ltd.
2925 Industrial Blvd.,
Laval, Quebec
H7L 2W9

Reason for Recall

The product is being recalled following a potential contamination with foreign material.

Depth of Recall - Distribution

Wholesalers and 1 pharmacy

Recall Posting Date

2010-08-02

Trade Name

Nordic Naturals Omega-3 Gummies

Recalling Firm

EcoTrend Ecologics Ltd.
125 - West 3rd Avenue
Vancouver, British Columbia
V5Y 1E6

Recall Start Date

2010-06-18

DIN, NPN, DIN-HM

NPN 80010832

Hazard Classification

Type II

Dosage Form

Soft Gummy Tablets

Strength

3g

Lot Number

NN9M04H3

Marketing Authorization Holder

Nordic Naturals, Inc.
94 Hangar Way
Watsonville, California
95076 USA

Reason for Recall

Labelling error - incorrect expiration date of December 2011 on product label. Correct expiration date should be June 2011.

Depth of Recall - Distribution

Across Canada (retail level distribution). No Export.

Recall Posting Date

2010-08-02

Trade Name

RAN-Ramipril

Recalling Firm

Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. East, Suite 200,
Mississauga, Ontario
L4W 0A5

Recall Start Date

2010-07-08

DIN, NPN, DIN-HM

DIN 02310503

Hazard Classification

Type II

Dosage Form

Capsules

Strength

1.25 mg

Lot Number

2086918, 2086923

Marketing Authorization Holder

Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. East, Suite 200,
Mississauga, Ontario
L4W 0A5

Reason for Recall

Isolation and identification of Aeromonas hydrophila / caviae.after conduct of Microbial Enumeration (Eur. Pharm. 2.6.12) and Specified Microorganisms (Eur. Pharm 2.6.13) testing.

Depth of Recall - Distribution

Product sold to wholesalers and to Jamp Pharma (Lot 2086918 only). No product was exported by Ranbaxy to foreign countries.

Recall Posting Date

2010-08-02

Trade Name

Triple Blend Echinacea (Alcohol Free) 50 ml

Recalling Firm

Swiss Herbal Remedies Limited (Packager)
35 Fulton Way
Richmond Hill, Ontario
L4B 2N4

Recall Start Date

2010-07-05

DIN, NPN, DIN-HM

No NPN

Hazard Classification

Type II

Dosage Form

Liquid

Strength

50 ml

Lot Number

Triple Blend Echinacea (Alcohol Free) 50 ml
Lot 35021

Marketing Authorization Holder

N/A

Reason for Recall

Consumer complaint reported to Swiss Herbal Remedies indicated solid particles and bad smell in the product "Echinacea & Goldenseal (alcohol free) 50mL". Testing conducted by the company revealed the presence of yeast and mould in the product. Further investigation revealed products Echinacea Extract (alcohol free) 50mL, Triple Blend Echinacea (Alcohol Free) 50mL and Echinacea Kid's (alcohol Free) 50mL manufactured using same bulk material may also been affected.

Depth of Recall - Distribution

Retailers - National (Alberta, British Columbia, Ontario, New Brunswick, Nova Scotia, Quebec, Saskatchewan, Manitoba, Newfoundland/Labrador, Prince Edward Island). Exports - None.

Recall Posting Date

2010-08-02

Trade Name

UP Ultimate Performance Daily Formula

Recalling Firm

Vitality Research Canada Inc.
9000 Ste. 244-231 Trans Canada Highway
Salmon Arm, British Columbia

Recall Start Date

2010-06-23

DIN, NPN, DIN-HM

No NPN

Hazard Classification

Type I

Dosage Form

Capsules

Strength

450 mg. blend of herbal ingredients

Lot Number

N/A

Marketing Authorization Holder

N/A

Reason for Recall

Product being sold without market authorization. Advised by the distributor that Ultimate Performance Daily Formula is from the same formulation and batch lot as with the Ultimate Performance For Men (which has been analysed to contain undeclared sildenafil at 54.2 mg/cap). Product suspected to contain undeclared Sildenafil, a Schedule F drug at a level of 54.2 mg/capsule.

Depth of Recall - Distribution

Distribution to retail stores in British Columbia. No export.

Recall Posting Date

2010-08-02

Trade Name

UP Ultimate Performance For Men

Recalling Firm

Vitality Research Canada Inc.
9000 Ste. 244-231 Trans Canada Highway
Salmon Arm, British Columbia

Recall Start Date

2010-06-23

DIN, NPN, DIN-HM

No NPN

Hazard Classification

Type I

Dosage Form

Capsules

Strength

450 mg. blend of herbal ingredients

Lot Number

N/A

Marketing Authorization Holder

N/A

Reason for Recall

Product being sold without market authorization. Product analysed by Inspectorate Lab found to contain undeclared Sildenafil, a Schedule F drug at a level of 54.2 mg/capsule.

Depth of Recall - Distribution

Distribution to retail stores in British Columbia. No export.

Recall Posting Date

2010-08-02

Trade Name

UP Ultimate Performance For Women

Recalling Firm

Vitality Research Canada Inc.
9000 Ste. 244-231 Trans Canada Highway
Salmon Arm, British Columbia

Recall Start Date

2010-06-23

DIN, NPN, DIN-HM

No NPN

Hazard Classification

Type I

Dosage Form

Capsules

Strength

450 mg. blend of herbal ingredients

Lot Number

N/A

Marketing Authorization Holder

N/A

Reason for Recall

Advised by the distributor that Ultimate Performance For Women is from the same formulation and batch lot as with the Ultimate Performance For Men (which has been analysed to contain undeclared sildenafil at 54.2 mg/cap). Product suspected to contain undeclared Sildenafil, a Schedule F drug at a level of 54.2 mg/capsule.

Depth of Recall - Distribution

Distribution to retail stores in British Columbia. No export.

Recall Posting Date

2010-08-02

Trade Name

Yan Chai Tong Reishi Bak Foong Pills

Recalling Firm

United Herbal Trading Company Limited
18-1833 Coast Meridian Road,
Port Coquitlam, British Columbia.
V3C 6G5

Recall Start Date

2010-06-04

DIN, NPN, DIN-HM

No NPN

Hazard Classification

Unacceptable risk to health

Dosage Form

Packets

Strength

N/A

Lot Number

All Lots

Marketing Authorization Holder

N/A

Reason for Recall

The product poses an unacceptable risk to health due to the product not being issued market authorization.

Depth of Recall - Distribution

Distributed to retail outlets in Canada (nationwide). No exports.

Recall Posting Date

2010-07-19

Trade Name

Liquid Win Rho SDF

Recalling Firm

Cangene Corporation
155 Innovation Drive
Winnipeg, Manitoba
R3T 5Y3

Recall Start Date

2010-06-29

DIN, NPN, DIN-HM

DIN 02302551

Hazard Classification

Type III

Dosage Form

Liquid

Strength

600 IU (120 ?g)

Lot Number

11006661, 11006833

Marketing Authorization Holder

Cangene Corporation
155 Innovation Drive
Winnipeg, Manitoba
R3T 5Y3

Reason for Recall

Precautionary measure based on seal defects found during packaging operations.

Depth of Recall - Distribution

Distributed throughout Canada by Canadian Blood Services and H‚ma-Qu‚bec.

Recall Posting Date

2010-07-19

Trade Name

Ma Pak Leung Po Ying Dan

Recalling Firm

Wing Quon Enterprises Ltd.
105-115, 6660 Graybar Road
Richmond, British Columbia
V6W 1H9

Recall Start Date

2010-06-21

DIN, NPN, DIN-HM

No NPN

Hazard Classification

Type II

Dosage Form

Powder

Strength

Each 0.26g vial contains:
Arissaeme erubescens Maxim (47 mg)
Uncaria rhynchophyll (Miq.) Jacks (47 mg)
Magnolia officinalis Rehd. et Wils. (47 mg)
Bambusa textillis McClure (18 mg)
Perilla frutescens (L.) Britt (18 mg)
Buthus martensii Karsch (17 mg)
Bombyx bori L. (17 mg)
Pinaceae (26 mg)
Dryobalanops aromatica Gaertner (17 mg)
Pteria martensi (Dunker) (6 mg)

Lot Number

All lots

Marketing Authorization Holder

N/A

Reason for Recall

Natural health product intended for use by children posing an unacceptable risk to health.

Depth of Recall - Distribution

Wholesale and retail stores in Quebec, Ontario, Alberta and British Columbia. No exportation.

Recall Posting Date

2010-07-05

Trade Name

Cancidas

Recalling Firm

Merck Frosst Canada Ltd.
16711 Trans Canada highway
Kirkland, Quebec
H9H 3L1

Recall Start Date

2010-06-08: Type II
2010-06-10: Type I

DIN, NPN, DIN-HM

DIN 02244265

Hazard Classification

Type I

Dosage Form

Powder for solution for infusion

Strength

50mg/vial

Lot Number

0204Y
1513X
1734X

Marketing Authorization Holder

Merck Frosst Canada Ltd.
16711 Trans Canada highway
Kirkland, Quebec
H9H 3L1

Reason for Recall

Recall initiated due to the potential for a limited number of cracked vials to be present in the recalled lots. If a crack should occur in the vial, its integrity and sterility may be compromised. The use of product from a cracked vial may present a risk of infection to patients, if the vial has become contaminated, or result in reduced product efficacity and underdosing.

Depth of Recall - Distribution

Wholesalers, pharmacies in health institutions - no exportation..

Recall Posting Date

2010-07-05

Trade Name

Longisil

Recalling Firm

Vetoquinol Inc.
2000 Georges Road,
Lavaltrie, Quebec
J5T 3S5

Recall Start Date

2010-06-15

DIN, NPN, DIN-HM

DIN 00461679

Hazard Classification

Type I

Dosage Form

Suspension

Strength

Penicillin G Benzathine 150 000 unit/ml
Penicillin G Procaine 150 000 unit/ml

Lot Number

Root lot (L) 0083 packaged into 3 lots of finished product
(L) 0083-01 (100 ml)
(L) 0083-02 (250 ml)
(L) 0083-03 (500 ml)

Marketing Authorization Holder

Vetoquinol Inc.
2000 Georges Road,
Lavaltrie, Quebec
J5T 3S5

Reason for Recall

Detection of an usually high level of adverse drug reactions similar to allergic reactions (urticaria, oedema) within minutes to hours following injection of the product.

Depth of Recall - Distribution

Wholesalers, veterinary clinics and swine integrators. Exports to Jamaica and Barbados.