Drug Recall Listings - Sorted by Trade Name

(From July 2005 - September 2005)

Trade Name

AC&C Tablets

Recall Posting Date

2005-07-11

Recalling Firm

Vita Health Products
150 Beghin Avenue
Winnipeg, Manitoba
R2J 3W2

Recall Start Date

2005-06-06

DIN, NPN, DIN-HM

00688851

Hazard Classification

Type III

Dosage Form

Tablet

Strength

325 mg

Lot Number

3B10203CU, 3B1020509, 3B102050L, 3B10206GW, 3B10206GX, 3B102070N, 3B102072W, 3B102083R, 3C068072, 3C068081L, 3C068083R, 3C0680959, 3C06809FF, 3C06809FG

Marketing Authorization Holder

Vita Health Products
150 Beghin Avenue
Winnipeg, Manitoba
R2J 3W2

Reason for Recall

The 24 month stability testing associated with the affected lots failed to meet specifications for tablet disintegration.

Depth of Recall - Distribution

Distribution of COOP, Equate, London Drug and Safeway brands across Canada.

Trade Name

BaumEssence

Recall Posting Date

2005-08-08

Recalling Firm

Cosmitty Canada
2822 Saint-Laurent Street
Lévis, Quebec
G6V 8P9

Recall Start Date

2005-06-22

DIN, NPN, DIN-HM

N

Hazard Classification

Unacceptable Risk Health as specified in the document "Compliance policy for the natural health products".

Dosage Form

Cream

Strength

N

Lot Number

N

Marketing Authorization Holder

N

Reason for Recall

Natural Heath product which does not have a valid market authorization and is intended to be used by children aged 12 and under.

Depth of Recall - Distribution

The product is distributed in Quebec by natural health products stores and esthetician boutiques.

Trade Name

Cardio Wise

Recall Posting Date

2005-09-05

Recalling Firm

Body-Wise Internationnal (Canada) Inc.
Unit 14
50 West Wilmont street
Richmond Hill,Ontario
L4B 1M5

Recall Start Date

2005-08-04

DIN, NPN, DIN-HM

N

Hazard Classification

Type III

Dosage Form

Capsule

Strength

50mg

Lot Number

411055, 412068, 502090, 403197, 501160

Marketing Authorization Holder

Product does not have Market Authorization

Reason for Recall

L-Carnitine available by prescription only.

Depth of Recall - Distribution

Products were sold across Canada, Alberta, BC, Manitoba, Newfoundland, Ontario,Quebec, Saskatchewan.

Trade Name

Children's Chewable Multivitamins with Iron Bonus Size

Recall Posting Date

2005-09-05

Recalling Firm

Jamieson Laboratories Ltd.
4025 Rhodes Road
Windsor, Ontario
N8W 5B5

Recall Start Date

2005-07-21

DIN, NPN, DIN-HM

00531731

Hazard Classification

Type III

Dosage Form

Tablet

Strength

CALCIUM D-PANTOTHENATE 10mg
D-ALPHA TOCOPHERYL ACID SUCCINATE 5 IU
IRON (FERROUS FUMARATE) 5mg
NICOTINAMIDE 10mg
VITAMIN A (VITAMIN A ACETATE) 5000 IU
VITAMIN B1 (THIAMINE MONONITRATE) 1.5mg
VITAMIN B12 6mcg
VITAMIN B2 1.2mg
VITAMIN B6 (PYRIDOXINE HYDROCHLORIDE) 1mg
VITAMIN C 100mg
VITAMIN D (VITAMIN D ACETATE) 400IU

Lot Number

683786, 822507

Marketing Authorization Holder

Jamieson Laboratories Ltd.
4025 Rhodes Road
Windsor, Ontario
N8W 5B5

Reason for Recall

Label indicates each tablet contains 5000IU Vitamin A while actual amount is 1600IU.

Depth of Recall - Distribution

One lot was exported primarily to Jordan. One lot was distributed primarily to retail stores across Canada.

Trade Name

Ciplastin Injection

Recall Posting Date

2005-08-08

Recalling Firm

Mayne Pharma Inc.
18100 Transcanadienne
Kirkland, Quebec
Canada
H9J 4A1

Recall Start Date

2005-07-18

DIN, NPN, DIN-HM

02126613

Hazard Classification

Type II

Dosage Form

Solution

Strength

1 mg

Lot Number

10 mg/10 mL : P011843

50 mg/50 mL :N011848, N021848 ,P011848, P021848
R011848

100 mg/100 mL :M041858, M051858 , M061858, N011858, N021858, N031858, N041858, N051858, N061858, P011858, P021858, P041858,P051858, P061858, P071858, P081858, R011858, R021858

Marketing Authorization Holder

Mayne Pharma Inc.
18100 Transcanadienne
Kirkland, Quebec
Canada
H9J 4A1

Reason for Recall

Out of specification results of degradation product, Trichloroamineplatinate (TCAP), occuring in stability studies

Depth of Recall - Distribution

Hospitals, wholesalers and distribution centres in Canada only. / Hôpitaux, grossistes et centres de distribution au Canada seulement.

Trade Name

Ciprodex

Recall Posting Date

2005-09-05

Recalling Firm

Alcon Laboratories Inc.
2665 Meadowpine Blvd.
Mississauga, Ontario
L5N 8C7

Recall Start Date

2005-07-25

DIN, NPN, DIN-HM

02252716

Hazard Classification

Type III

Dosage Form

Sterile Otic Suspension

Strength

0.3 % and 0.1 % respectively.

Lot Number

72540F

Marketing Authorization Holder

Alcon Laboratories Inc.
2665 Meadowpine Blvd.
Mississauga, Ontario
L5N 8C7

Reason for Recall

A leak in a VHP generator used for decontaminating the isolators in one step of the manufacturing process. The finished product met all of its finished product specifications, including sterility.

Depth of Recall - Distribution

Distributed to 15 customers (5 hospitals and 10 wholesalers) in Ontario, Quebec, Newfoundland, and Nova Scotia.

Trade Name

Creo-Rectal Nourrisson

Recall Posting Date

2005-09-05

Recalling Firm

Sabex Inc.
145 Jules-Léger
Boucherville, Québec
Canada
J4B 7K8

Recall Start Date

2005-08-09

DIN, NPN, DIN-HM

00299588

Hazard Classification

Type II

Dosage Form

Suppository

Strength

Diphenylpyraline HCI: 0.25MG / Suppositary
Guaiacol Carbonate : 100mg / Suppositary
Camphor : 1mg / Suppositary

Lot Number

119281

Marketing Authorization Holder

Sabex Inc.
145 Jules-Léger
Boucherville, Québec
Canada
J4B 7K8

Reason for Recall

Out of Specification results for the assay of Diphenylpyraline HCl, occuring in stability studies at 18 months. The expiry date is 26 months. The stability specification for the assay of Diphenylpyraline HCl is 0.2250-0.2750 mg

Depth of Recall - Distribution

Hospitals, pharmacies and wholesalers across Canada only

Trade Name

Delflex Peritoneal Dialysis Solution, 1.5% Dextrose

Recall Posting Date

2005-07-11

Recalling Firm

Fresenius Medical Care Canada
25B East Pearce
Richmond Hill, Ontario
L4B 2M9

Recall Start Date

2005-06-02

DIN, NPN, DIN-HM

02025531

Hazard Classification

Type I (Long term Exposure)

Type II (Short term exposure)

Dosage Form

Liquid

Strength

Dextrose 1.5 g / 100ml
Calcium Chloride 18.4 mg / 100ml
Magnesium Chloride 5.08 mg / 100ml
Sodium Chloride 538 mg / 100ml
Sodium Lactate 448 mg / per 100ml solution

Lot Number

All Lots

Marketing Authorization Holder

Fresenius USA, Inc.
95 Hayden Avenue
Lexington, Massachusetts
USA
02420-9192

Reason for Recall

Aluminium concentration in the solution exceeds British Pharmacopea standard of 15ppb. The sale of the product contravenes Section C.01.011(4) of the Food and Drugs Regulation.

Depth of Recall - Distribution

Products are shipped to clinics or directly to patients in Ontario, Québec and Newfoundland.

Trade Name

Delflex Peritoneal Dialysis Solution, 1.5% Dextrose

Recall Posting Date

2005-07-11

Recalling Firm

Fresenius Medical Care Canada
25B East Pearce
Richmond Hill, Ontario
L4B 2M9

Recall Start Date

2005-06-02

DIN, NPN, DIN-HM

02025477

Hazard Classification

Type I (Long term Exposure)

Type II (Short term exposure)

Dosage Form

Liquid

Strength

Dextrose 1.5 g
Calcium Chloride 25.7 mg
Magnesium Chloride 15.2 mg
Sodium Chloride 567 mg
Sodium Lactate 392 mg / per 100ml solution

Lot Number

All Lots

Marketing Authorization Holder

Fresenius USA, Inc.
95 Hayden Avenue
Lexington, Massachusetts
USA
02420-9192

Reason for Recall

Aluminium concentration in the solution exceeds British Pharmacopea standard of 15ppb. The sale of the product contravenes Section C.01.011(4) of the Food and Drugs Regulation.

Depth of Recall - Distribution

Products are shipped to clinics or directly to patients in Ontario, Québec and Newfoundland.

Trade Name

Delflex Peritoneal Dialysis Solution, 2.5% Dextrose

Recall Posting Date

2005-07-11

Recalling Firm

Fresenius Medical Care Canada
25B East Pearce
Richmond Hill, Ontario
L4B 2M9

Recall Start Date

2005-06-02

DIN, NPN, DIN-HM

02025523

Hazard Classification

Type I (Long term Exposure)

Type II (Short term exposure)

Dosage Form

Liquid

Strength

Dextrose 2.5 g
Calcium Chloride 18.4 mg
Magnesium Chloride 508 mg
Sodium Chloride 538 mg
Sodium Lactate 448 mg / per 100ml solution

Lot Number

All Lots

Marketing Authorization Holder

Fresenius USA, Inc.
95 Hayden Avenue
Lexington, Massachusetts
USA
02420-9192

Reason for Recall

Aluminium concentration in the solution exceeds British Pharmacopea standard of 15ppb. The sale of the product contravenes Section C.01.011(4) of the Food and Drugs Regulation.

Depth of Recall - Distribution

Distributed Peritoneal Dialysis to clinics associated with hospitals in Ontario, Québec and Newfoundland.

Trade Name

Delflex Peritoneal Dialysis Solution, 2.5% Dextrose

Recall Posting Date

2005-07-11

Recalling Firm

Fresenius Medical Care Canada
25B East Pearce
Richmond Hill, Ontario
L4B 2M9

Recall Start Date

2005-06-02

DIN, NPN, DIN-HM

02025485

Hazard Classification

Type I (Long term Exposure)

Type II (Short term exposure)

Dosage Form

Liquid

Strength

Dextrose 2.5 g
Calcium Chloride 25.7 mg
Magnesium Chloride 15.2 mg
Sodium Chloride 567 mg
Sodium Lactate 392 mg/ per 100ml solution

Lot Number

All Lots

Marketing Authorization Holder

Fresenius USA, Inc.
95 Hayden Avenue
Lexington, Massachusetts
USA
02420-9192

Reason for Recall

Aluminium concentration in the solution exceeds British Pharmacopea standard of 15ppb. The sale of the product contravenes Section C.01.011(4) of the Food and Drugs Regulation.

Depth of Recall - Distribution

Products are shipped to clinics or directly to patients in Ontario, Québec and Newfoundland.

Trade Name

Delflex Peritoneal Dialysis Solution, 4.25% Dextrose

Recall Posting Date

2005-07-11

Recalling Firm

Fresenius Medical Care Canada
25B East Pearce
Richmond Hill, Ontario
L4B 2M9

Recall Start Date

2005-06-02

DIN, NPN, DIN-HM

02025930

Hazard Classification

Type I (Long term Exposure)

Type II (Short term exposure)

Dosage Form

Liquid

Strength

Dextrose 4.25 g
Calcium Chloride 18.4 mg
Magnesium Chloride 508 mg
Sodium Chloride 538 mg
Sodium Lactate 448 mg / per 100ml solution

Lot Number

All Lots

Marketing Authorization Holder

Fresenius USA, Inc.
95 Hayden Avenue
Lexington, Massachusetts
USA
02420-9192

Reason for Recall

Aluminium concentration in the solution exceeds British Pharmacopea standard of 15ppb. The sale of the product contravenes Section C.01.011(4) of the Food and Drugs Regulation.

Depth of Recall - Distribution

Distributed Peritoneal Dialysis to clinics associated with hospitals in Ontario, Québec and Newfoundland.

Trade Name

Delflex Peritoneal Dialysis Solution, 4.25% Dextrose

Recall Posting Date

2005-07-11

Recalling Firm

Fresenius Medical Care Canada
25B East Pearce
Richmond Hill, Ontario
L4B 2M9

Recall Start Date

2005-06-02

DIN, NPN, DIN-HM

02025507

Hazard Classification

Type I (Long term Exposure)

Type II (Short term exposure)

Dosage Form

Liquid

Strength

Dextrose 4.25 g
Calcium Chloride 25.7 mg
Magnesium Chloride 15.2 mg
Sodium Chloride 567 mg
Sodium Lactate 392 mg / per 100ml solution

Lot Number

All Lots

Marketing Authorization Holder

Fresenius USA, Inc.
95 Hayden Avenue
Lexington, Massachusetts
USA
02420-9192

Reason for Recall

Aluminium concentration in the solution exceeds British Pharmacopea standard of 15ppb. The sale of the product contravenes Section C.01.011(4) of the Food and Drugs Regulation.

Depth of Recall - Distribution

Products are shipped to clinics or directly to patients in Ontario, Québec and Newfoundland.

Trade Name

Ketorolac Tromethamine Injection USP

Recall Posting Date

2005-09-05

Recalling Firm

Sabex Inc.
145 Jules-Léger
Boucherville, Quebec
Canada
J4B 7K8

Recall Start Date

2005-08-04

DIN, NPN, DIN-HM

02239944

Hazard Classification

Type III

Dosage Form

Solution

Strength

30mg

Lot Number

118707

Marketing Authorization Holder

Sabex Inc.
145 Jules-Léger
Boucherville, Québec
Canada
J4B 7K8

Reason for Recall

Out of specification results of a known impurity, Ketorolac 1-keto Analog, occuring in stability studies at 18 months (results 0.3%, specification ?0.2%).

Depth of Recall - Distribution

Hospitals, pharmacies and wholesalers across Canada only

Trade Name

La Racine de Vie

Teinture d'Échinacée - Formule pour enfant(Sans Alcool) / Echinacea Tincture - Children Formula(Alcohol Free)

Recall Posting Date

2005-09-19

Recalling Firm

Laboratoires Colba Inc.
550 Deslauriers Street
St-Laurent, Québec
Canada
H4N 1V8

Recall Start Date

2005-08-26

DIN, NPN, DIN-HM

N

Hazard Classification

Unacceptable Risk Health as specified in the document "Compliance policy for the natural health products".

Dosage Form

Solution

Strength

200 mg

Lot Number

312036, 412007, 501004, 503009

Marketing Authorization Holder

N

Reason for Recall

Natural Heath product which does not have a valid market authorization and is intended to be used by children.

Depth of Recall - Distribution

Distributed in Pharmacies and wholesalers in Quebec and Ontario only.

Trade Name

LifeTime

Recall Posting Date

2005-07-11

Recalling Firm

LifeTime Nutrition
Unit 107
12414-8 2nd Ave.
Surrey, British Columbia
V3W 3E9

Recall Start Date

N

DIN, NPN, DIN-HM

N

Hazard Classification

Type II

Dosage Form

Capsules

Strength

50 mg

Lot Number

0402023, 0404006, 0411049, 0412009

Marketing Authorization Holder

LifeTime Nutritional Specialties Inc.
Anaheim, California
************
LifeTime Nutritional Specialties Inc.
Anaheim (California)

Reason for Recall

Selling Schedule F drug over the counter without a DIN.

Depth of Recall - Distribution

Brithish Columbia only

Trade Name

Loris

Recall Posting Date

2005-09-05

Recalling Firm

LernaPharm (Loris) Inc.
2323 Halpern
Ville St-Laurent , Québec
H4S 1S3

Recall Start Date

2005-07-29

DIN, NPN, DIN-HM

02248362

Hazard Classification

Type III

Dosage Form

Tampon

Strength

Alcool Isopropylique 70%

Lot Number

N

Marketing Authorization Holder

LernaPharm (Loris) Inc.
2323 Halpern
Ville St-Laurent , Québec
H4S 1S3

Reason for Recall

The recalled products are those where the pads are without DIN and those with the DIN but the lot number and the expiry date are illegible.

Depth of Recall - Distribution

The product is distributed in hospitals and medical clinics.

Trade Name

Paxil 20mg Tablets

Recall Posting Date

2005-08-08

Recalling Firm

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

Recall Start Date

2005-07-11

DIN, NPN, DIN-HM

01940481

Hazard Classification

Type II

Dosage Form

Tablet

Strength

20mg

Lot Number

2025B11

Marketing Authorization Holder

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

Reason for Recall

Lot is at risk of containing higher level of paroxetine than specification due to content uniformity issue (estimated that less than 1% of tablets affected).

Depth of Recall - Distribution

Lot 2025B11 was distributed to wholesalers, retail pharmacies, and hospitals in Canada.Same batch of tablets was packaged in Canada and exported to USA.

Trade Name

Pro Pure

Recall Posting Date

2005-09-05

Recalling Firm

Body-Wise Internationnal (Canada) Inc.
Unit 14
50 West Wilmont street
Richmond Hill,Ontario
L4B 1M5

Recall Start Date

2005-08-04

DIN, NPN, DIN-HM

N

Hazard Classification

Type III

Dosage Form

Topical Cream

Strength

960mg Natural Progesterone USP per 2 oz

Lot Number

All Lots

Marketing Authorization Holder

Product does not have Market Authorization

Reason for Recall

Progesterone cream available by prescription only.

Depth of Recall - Distribution

Products were sold across Canada, Alberta, BC, Manitoba, Newfoundland, Ontario,Quebec, Saskatchewan.

Trade Name

Ratio-Paroxetine 20mg

Recall Posting Date

2005-08-08

Recalling Firm

Ratiopharm
17800 Lapointe Street
Mirabel, Quebec
Canada
J7J 1P3

Recall Start Date

2005-07-08

DIN, NPN, DIN-HM

02247811

Hazard Classification

Type II

Dosage Form

Tablet

Strength

20 mg (per tablet

Lot Number

15P22

Marketing Authorization Holder

Ratiopharm
17800 Lapointe Street
Mirabel, Quebec
Canada
J7J 1P3

Reason for Recall

Content uniformity - a small number of tablets at the end of compression may have higher than specification levels of paroxetine.

Depth of Recall - Distribution

Wholesalers in Canada Only

Trade Name

Sweet Ease

Recall Posting Date

2005-09-19

Recalling Firm

Respironics Inc.
1001 Murry Ridge Lane
Murrysville, Pennsylvania
15668

Recall Start Date

2005-07-25

DIN, NPN, DIN-HM

N

Hazard Classification

Type I

Dosage Form

Liquid

Strength

24% Sucrose (Solution)

Lot Number

1365

Marketing Authorization Holder

McArthur Medical Sales Inc.
1846 5th Concession West
Rockton, Ontario
L0R 1X0

Reason for Recall

Mold Contmination.

Depth of Recall - Distribution

Distributed in hospitals and doctor's offices in Alberta Ontario and Quebec.

Trade Name

Viva Toro Energy Drink

Recall Posting Date

2005-07-11

Recalling Firm

Viva Toro Beverage Company Inc.
Langley, British Columbia
Canada

Recall Start Date

2005-05-05

DIN, NPN, DIN-HM

N

Hazard Classification

Type II

Dosage Form

Oral Liquid

Strength

1000 mg

Lot Number

5V101

Marketing Authorization Holder

Viva Toro Beverage Company Inc.
Langley, British Columbia
Canada

Reason for Recall

Undeclared ingredients, absence of cautionary statement.

Depth of Recall - Distribution

Distributed to retail through a wholesaler in Vancouver area only.

Trade Name

Workout Formula

Recall Posting Date

2005-09-05

Recalling Firm

Body-Wise Internationnal (Canada) Inc.
Unit 14
50 West Wilmont street
Richmond Hill,Ontario
L4B 1M5

Recall Start Date

2005-08-04

DIN, NPN, DIN-HM

N

Hazard Classification

Type III

Dosage Form

Capsule

Strength

200mg

Lot Number

410194, 501020

Marketing Authorization Holder

Product does not have Market Authorization

Reason for Recall

L-Carnitine available by prescription only.

Depth of Recall - Distribution

Products were sold across Canada, Alberta, BC, Manitoba, Newfoundland, Ontario,Quebec, Saskatchewan.