Drug Recall Listings - Sorted by Trade Name

(From April 2009 - June 2009)

Trade Name

A) LD Senna Lax 8.6MG N/S 100TB B) PS Senna Laxative 8.6MG Tabs 120 C) JAMP Senna Lax 8.6MG 100TB D) JAMP Senna Lax 8.6MG 500TB E) FMPX Senna Laxative 8.6MG 100TB F) RXLL Senna Laxative N/S 100 TB G) PJC Senna Lax 8.6MG 100+20TB H) SAM Senna Laxative 8.6MG 180TB

Recall Posting Date

2009-04-27

Recalling Firm

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

Recall Start Date

2009-04-13

DIN, NPN, DIN-HM

NPN 02237105 (note: due to the DIN/NPN transitions, product may also be labelled with the DIN 02237105)

Hazard Classification

Type II

Dosage Form

Tablets

Strength

8.6 mg

Lot Number

A) LD Senna Lax 8.6MG N/S 100TB 6L03015QT, 6L03115QT, 6L03617N2, 7C12018PK, 7G0101A0A, 7G0111AQY, 7H0901C5U, 7H0901F0J, 8A0251FJY, 8G0361JMC, 8H0501LSF, 8H0501MB6, 8J0241N7Z B) PS Senna Laxative 8.6MG Tabs 120 7C12118FH,7H0881B5V C) JAMP Senna Lax 8.6MG 100TB 8H0501LSM D) JAMP Senna Lax 8.6MG 500TB 8I0961MKF E) FMPX Senna Laxative 8.6MG 100TB 6L03517TL, 6L03617TL, 7C120194R, 7G0101AES, 7G01119GJ, 7H0881B6Q, 8A0251FYQ, 8A0261KU9, 8G0351J45, 8G0361KU9, 8I0961N3Q, 8J0241PBA F) RXLL Senna Laxative N/S 100 TB 8A0251GN0, 8A0261GN0, 8G0351HVP, 8H0501LSH, 8I0951MAZ, 8I0961MRN, 6H08612UV, 6L03115VU, 7C120194U, 7G0111A08, 7G0111BCS, 7H0881BCS, 7H0901CXN G) PJC Senna Lax 8.6MG 100+20TB 6H08612GE, 6L02915K7, 6L03216QY, 7C12118JR, 7G01119HS, 7G0111BFS, 7H0881BFS, 7H0881C6W, 7H0901CBV, 8A0251FK0, 8D1121HEX, 8G0361JMB, 8I0961MBT, 8I0961N1A, 8J0241P34 H) SAM Senna Laxative 8.6MG 180TB 6H08612K0, 6L03217N4, 6L03517N4, 7H0881AQX, 7H0901CXL, 8A0261GN2, 8G0361KEW, 8H0501MB4

Marketing Authorization Holder

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

Reason for Recall

The manufacturer initiated a class II voluntarily recall of the affected lots because they contain small amounts of undeclared anhydrous lactose and tartaric acid.

Depth of Recall - Distribution

Distributed across Canada.

Trade Name

A) Truly Senna Laxative Tablets 100TB B) SW Senna Laxative 71045361 100TB C) OVWT Senna Lax 8.6 mg N/S 100TB D) Exact Senna Lax 8.6MG N/S 100TB E) BRNT Senna Laxative 8.6MG 100TB F) Equate Senna Lax 8.6MG 100TB G) Metro Senna Laxative 8.6MG 100 TB H) LD Senna Lax 8.6MG N/S 100TB

Recall Posting Date

2009-04-27

Recalling Firm

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

Recall Start Date

2009-04-13

DIN, NPN, DIN-HM

NPN 02237105 (note: due to the DIN/NPN transitions, product may also be labelled with the DIN 02237105)

Hazard Classification

Type II

Dosage Form

Tablets

Strength

8.6 mg

Lot Number

A) Truly Senna Laxative Tablets 100TB 6H11012UX, 6L03215ET, 6L03617N3, 7C12018PJ, 7C12019B2 , 7C121187F, 7G0101A06, 7G0101AJX, 7H0881BUN, 8A0251FJV, 8G0351HKY, 8H0501LSG, 8I0961MB1, 8I0961MB1, 8I0961MP4 B) SW Senna Laxative 71045361 100TB 6H08612NC, 6L03115EZ, 6L03615EZ, 6L03617QZ, 7G0101AAR, 8A0261FJT, 8G0351HVM, 8H0501LSK, 8I0951N7Y, 8I0961N7Y, 8J0241N7Y, 8J0241P35 C) OVWT Senna Lax 8.6 mg N/S 100TB 8J0241N81, 8J0241P7C, 6L03215QS, 7C120194S, 7G0111A07, 7G0111AY1, 7H0901CFY, 8A0251G5T, 8G0351HVR, 8H0501LFF D) Exact Senna Lax 8.6MG N/S 100TB 8G0361KEY, 8H0501LPK, 8I0951MB2, 8G0361K2L, 8H0501LUP, 8H0501MK6, 8I0961MK6, 6H08612UU, 6H11012UU, 6L03015EW, 7C12117R0, 7G0101A0B, 7G0101AQV, 7G0111AQV, 7H0881C5V, 7H0901C5V, 7H0901CXE, 8A0261G5R E) BRNT Senna Laxative 8.6MG 100TB 7C120194T F) Equate Senna Lax 8.6MG 100TB 6H08612UW, 6L02915EU, 6L03015EU, 6L03517N1, 7C120194V, 7G0111AY0, 7H0881AY0, 7H0881BK1, 7H0901CXF, 8A0261GN3, 8G0351J6R, 8G0361KQA, 8I0951M4K, 8J0241P36 G) Metro Senna Laxative 8.6MG 100 TB 8A0251EBF, 8G0351HBB, 8H0501LSJ, 8I0961MRM, 8J0241PFH

Marketing Authorization Holder

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

Reason for Recall

The manufacturer initiated a class II voluntarily recall of the affected lots because they contain small amounts of undeclared anhydrous lactose and tartaric acid.

Depth of Recall - Distribution

Distributed across Canada.

Trade Name

Apo-Clindamycin 150 mg

Recall Posting Date

2009-04-27

Recalling Firm

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

Recall Start Date

2009-04-09

DIN, NPN, DIN-HM

DIN 02245232

Hazard Classification

Type II

Dosage Form

Capsules

Strength

150 mg

Lot Number

Lots - Canada HL0314, HM7817, HP9023, HT1470, HV8933, HY7888 Lots - International Market HL0314, HT1470, HY7888, JC7887

Marketing Authorization Holder

N/A

Reason for Recall

The manufacturer of the Clindamycin active raw material also manufactures certain beta-lactam antibiotics and was found to have inadequate separation of these operations. While not confirmed, the possibility of cross-contamination exists. A Health Hazard Evaluation was conducted by both Health Canada and Apotex. Although the potential for serious adverse health consequences is remote, Apotex is voluntarily recalling this product as a precautionary measure due to the sensitizing nature of the potential cross-contaminants.

Depth of Recall - Distribution

Retail Pharmacies, Wholesalers, Doctors, Hospitals in Canada including the following Provinces and Territories: Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland & Labrador, Nova Scotia, Northwest Territories, Nunavut, Ontario, Prince Edward Island, Quebec, Saskatchewan, Yukon. Batches were also manufactured and packaged for Pro-Doc Ltee. in Laval, Quebec. Some of the lots also went to International customers in United Arab Emirates, Antigua and Barbuda, Anguilla, Barbados, Bermuda, Bahamas, Belize, Grenada, Guyana, Iran, Jamaica, Saint Kitts And Nevis, Cayman Islands, Saint Lucia, Montserrat, Mexico, Palau, Saudi Arabia, Trinidad and Tobago, Virgin Islands, British.

Trade Name

Apo-Clindamycin 300 mg

Recall Posting Date

2009-04-27

Recalling Firm

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

Recall Start Date

2009-04-09

DIN, NPN, DIN-HM

DIN 02245233

Hazard Classification

Type II

Dosage Form

Capsules

Strength

300 mg

Lot Number

Lots - Canada HL0325, HM7815, HP9022, HV2250, HV8931, HY7890 Lots - International Market HL0322, HL0325, HM7815, HM6711, HP9022, HV2250, HV8931, HY7890, JC7885

Marketing Authorization Holder

N/A

Reason for Recall

The manufacturer of the Clindamycin active raw material also manufactures certain beta-lactam antibiotics and was found to have inadequate separation of these operations. While not confirmed, the possibility of cross-contamination exists. A Health Hazard Evaluation was conducted by both Health Canada and Apotex. Although the potential for serious adverse health consequences is remote, Apotex is voluntarily recalling this product as a precautionary measure due to the sensitizing nature of the potential cross-contaminants.

Depth of Recall - Distribution

Retail Pharmacies, Wholesalers, Doctors, Hospitals in Canada including the following Provinces and Territories: Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland & Labrador, Nova Scotia, Northwest Territories, Nunavut, Ontario, Prince Edward Island, Quebec, Saskatchewan, Yukon. Batches were also manufactured and packaged for Pro-Doc Ltee. in Laval, Quebec. Some of the lots also went to International customers in United Arab Emirates, Antigua and Barbuda, Anguilla, Barbados, Bermuda, Bahamas, Belize, Grenada, Guyana, Iran, Jamaica, Saint Kitts And Nevis, Cayman Islands, Saint Lucia, Montserrat, Mexico, Palau, Saudi Arabia, Trinidad and Tobago, Virgin Islands, British.

Trade Name

Apo-Lithium Carbonate SR

Recall Posting Date

2009-06-22

Recalling Firm

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

Recall Start Date

2009-05-19

DIN, NPN, DIN-HM

DIN 02266695

Hazard Classification

Type II

Dosage Form

Tablet (Extended-Release)

Strength

300 mg

Lot Number

HP0395

Marketing Authorization Holder

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

Reason for Recall

Apotex Inc. initiated the recall following the identification of dissolution results exceeding the specification limit.

Depth of Recall - Distribution

Retail Pharmacies and Wholesalers across Canada.

Trade Name

Clindamycine-150

Recall Posting Date

2009-04-27

Recalling Firm

Prodoc Limited 2925 Industrial Blvd, Laval, Quebec H7L 3W9

Recall Start Date

2009-04-09

DIN, NPN, DIN-HM

DIN 02248525

Hazard Classification

Type II

Dosage Form

Capsules

Strength

150 mg

Lot Number

(L) 3390, (L) 3390-1

Marketing Authorization Holder

Prodoc Limited 2925 Industrial Blvd, Laval, Quebec H7L 3W9

Reason for Recall

The supplier of the raw material Clindamycin also manufactures certain beta-lactam antibiotics for which cross-contaminations may occur during the manufacturing process.

Depth of Recall - Distribution

Sold in Quebec only. The product is not exported.

Trade Name

Clindamycine-300

Recall Posting Date

2009-04-27

Recalling Firm

Prodoc Limited 2925 Industrial Blvd, Laval, Quebec H7L 3W9

Recall Start Date

2009-04-09

DIN, NPN, DIN-HM

DIN 02248526

Hazard Classification

Type II

Dosage Form

Capsules

Strength

300 mg

Lot Number

(L) 3641, (L) 3391, (L) 3215

Marketing Authorization Holder

Prodoc Limited 2925 Industrial Blvd, Laval, Quebec H7L 3W9

Reason for Recall

The supplier of the raw material Clindamycin also manufactures certain beta-lactam antibiotics for which cross-contaminations may occur during the manufacturing process.

Depth of Recall - Distribution

Sold in Quebec only. The product is not exported.

Trade Name

Dermaflex HC 1% Cream / Crème

Recall Posting Date

2009-06-22

Recalling Firm

Neolab Inc. (Distributor)
5476 Upper Lachine Road
Montreal, Quebec
H4A 2A4

Recall Start Date

2009-05-14

DIN, NPN, DIN-HM

DIN 00681989

Hazard Classification

Type III

Dosage Form

Cream / Crème

Strength

Hydrocortisone acetate 1% / Acétate d?hydrocortisone 1%

Lot Number

Lot R1021, Lot P0811

Marketing Authorization Holder

Neolab Inc. (Distributor)
5476 Upper Lachine Road
Montreal, Quebec
H4A 2A4

Reason for Recall

The Hydrocortisone acetate did not support a 36 months shelf-life when stored at World Health Organization specifications 250C± 20C. At 18 months, one lot recorded reaches a lower potency for Hydrocortisone acetate.

Depth of Recall - Distribution

Wholesalers and pharmacies in Canada only. No export.

Trade Name

Dermaflex HC 1% Lotion

Recall Posting Date

2009-06-22

Recalling Firm

Neolab Inc. (Distributor)
5476 Upper Lachine Road
Montreal, Quebec
H4A 2A4

Recall Start Date

2009-05-14

DIN, NPN, DIN-HM

DIN 00681997

Hazard Classification

Type III

Dosage Form

Lotion

Strength

Hydrocortisone acetate 1% / Acétate d?hydrocortisone 1%

Lot Number

Lot R0839, Lot P0321, Lot S0840

Marketing Authorization Holder

Neolab Inc. (Distributor)
5476 Upper Lachine Road
Montreal, Quebec
H4A 2A4

Reason for Recall

The Hydrocortisone acetate did not support a 36 months shelf-life when stored at World Health Organization specifications 250C± 20C. At 18 months, one lot recorded reaches a lower potency for Hydrocortisone acetate.

Depth of Recall - Distribution

Wholesalers and pharmacies in Canada only. No export.

Top of Page

Trade Name

Dobutamine Hydrochloride Injection

Recall Posting Date

2009-06-08

Recalling Firm

Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9

Recall Start Date

2009-05-15

DIN, NPN, DIN-HM

DIN 02228335

Hazard Classification

Type II

Dosage Form

Sterile Injectable Liquid

Strength

12.5 mg/ml

Lot Number

1156283

Marketing Authorization Holder

Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9

Reason for Recall

The labelling instructions on the vial indicate units of measure for dosing in the mg/kg/min range instead of in the ug/kg/min range which is 1000 times higher than the approved dosing range. The correct dosing range is specified on the carton text and on the patient information leaflets. A typographical error on the immediate container label is indicated as 2.5 to 10 mg/kg/min instead of 2.5 to 10 µg/kg/min.

Depth of Recall - Distribution

Distributed to Wholesalers and Hospitals across Canada. No exportation.

Top of Page

Trade Name

dom-Gabapentin

Recall Posting Date

2009-04-13

Recalling Firm

Dominion Pharmacal 6111 Royalmount Avenue, Suite 100 Montreal, Quebec H4P 2T4

Recall Start Date

2009-03-26

DIN, NPN, DIN-HM

DIN 02243745

Hazard Classification

Type II

Dosage Form

Capsule

Strength

400 mg

Lot Number

439795

Marketing Authorization Holder

Dominion Pharmacal 6111 Royalmount Avenue, Suite 100 Montreal, Quebec H4P 2T4

Reason for Recall

These lots are being recalled due to an error in the colour of the capsules that are red instead of orange.

Depth of Recall - Distribution

Wholesalers and pharmacies in Canada only. No exportation.

Top of Page

Trade Name

Duratocin

Recall Posting Date

2009-04-13

Recalling Firm

Ferring Inc. 200 Yorkland Boulevard, Suite 800 North York, Ontario M2J 5C1

Recall Start Date

2009-03-19

DIN, NPN, DIN-HM

DIN 02231593

Hazard Classification

Type III

Dosage Form

IV Injection

Strength

100 µg / mL

Lot Number

8A031A

Marketing Authorization Holder

Ferring Inc. 200 Yorkland Boulevard, Suite 800 North York, Ontario M2J 5C1

Reason for Recall

The noted lot of Duratocin is included in the on-going stability program and the results for testing of 2 known impurities are out of specification at the 12 months time point.

Depth of Recall - Distribution

Duratocin is a hospital product in Canada and the majority of sales are direct to hospitals with the exception of some sales in Quebec where the product is distributed through wholesalers to hospitals. This product has been on the Canadian market since January, 2000.

Top of Page

Trade Name

Irinotecan for Injection

Recall Posting Date

2009-04-13

Recalling Firm

Novopharm Limited 30 Novopharm Court Toronto, Ontario M1B 2K9

Recall Start Date

2009-03-26

DIN, NPN, DIN-HM

DIN 02312409

Hazard Classification

Type II

Dosage Form

Sterile Injectable Solution

Strength

20 mg/ml

Lot Number

(L)GB015A, (L)GB016A

Marketing Authorization Holder

Novopharm Limited 30 Novopharm Court Toronto, Ontario M1B 2K9

Reason for Recall

These batches showed turbidity created by crystals of Irinotecan. This was observed in some vials stored at 30 and 40 degrees Celsius in the inverted position.

Depth of Recall - Distribution

Distributed to Wholesalers and Hospitals across Canada. No exportation of this product has taken place.

Top of Page

Trade Name

Laxative Pills ES / Truly, Life Brand, Rexall, Preferred, Rexall, Encounter, Personnelle

Recall Posting Date

2009-05-11

Recalling Firm

Tanta Pharmaceuticals Inc., 1009 Burns Street East, Whitby, Ontario

Recall Start Date

2009-04-09

DIN, NPN, DIN-HM

NPN # 02245005

Hazard Classification

Type III

Dosage Form

Tablet

Strength

25 mg

Lot Number

M027T J108T F023U H049U

Marketing Authorization Holder

Tanta Pharmaceuticals Inc., 1009 Burns Street East, Whitby, Ontario

Reason for Recall

These lots are mislabeled. The products contain lactose and tartaric acid which are not declared on the list of non medicinal ingredients on the product labels.

Depth of Recall - Distribution

Distributed to retail pharmacies, wholesalers and private label customers in Ontario, New Brunswick, Quebec, Alberta, Manitoba, Saskatchewan, Newfoundland and British Columbia.

Top of Page

Trade Name

Laxative Pills Regular Strength (RS) 12s and 30s / Preferred, Texall, Tanta, Personnelle

Recall Posting Date

2009-05-11

Recalling Firm

Tanta Pharmaceuticals Inc., 1009 Burns Street East, Whitby, Ontario

Recall Start Date

2009-04-09

DIN, NPN, DIN-HM

DIN # 02245004* *distributed under DIN at time of recall, but presently sold under NPN # 02245004

Hazard Classification

Type III

Dosage Form

Tablet

Strength

15 mg

Lot Number

H097T

Marketing Authorization Holder

Tanta Pharmaceuticals Inc., 1009 Burns Street East, Whitby, Ontario

Reason for Recall

These lots are mislabeled. The products contain lactose and tartaric acid which are not declared on the list of non medicinal ingredients on the product labels.

Depth of Recall - Distribution

Distributed to retail pharmacies, wholesalers and private label customers in Ontario, New Brunswick, Quebec, Alberta, Manitoba, Saskatchewan, Newfoundland and British Columbia.

Top of Page

Trade Name

Maxum Multi Vite
Maxum Matragen

Recall Posting Date

2009-06-22

Recalling Firm

Seroyal
490 Elgin Mills Road East
Richmond Hill, Ontario
L4C 0L8

Recall Start Date

2009-05-19

DIN, NPN, DIN-HM

DIN 02229896

Hazard Classification

Type II

Dosage Form

Capsules

Strength

Vitamin A 450mcg
Beta Carotene 900mcg
Vitamin C 100mcg
Vitamin D 0.38mcg
Vitamin E 34mg
Thiamine 15mg
Riboflavin 17mg
Niacinamide 20mg
Vitamin B6 17mg
Folate 0.100mcg
Vitamin B12 30mcg
Biotin 50mcg

Lot Number

All

Marketing Authorization Holder

Seroyal
490 Elgin Mills Road East
Richmond Hill, Ontario
L4C 0L8

Reason for Recall

These products have not been evaluated and approved for use in pregnant and/or breast-feeding women. They contain Ginkgo biloba and vanadium for which the safety profile and the potential safety concerns are un-established for pregnant and/or breast-feeding women, and provide inadequate dosages of folate and iron for a prenatal supplement. The products also lack the required cautionary label warning consumers to consult with a health care practitioner prior to use if they are pregnant or breast-feeding.

Depth of Recall - Distribution

Product was distributed to healthcare professionals in Canada.

Top of Page

Trade Name

Min-Ovral 21

Recall Posting Date

2009-06-22

Recalling Firm

Wyeth Canada
1025 Marcel-Laurin Boulevard
St-Laurent, Quebec
H4R 1J6

Recall Start Date

2009-05-25

DIN, NPN, DIN-HM

DIN 02042320

Hazard Classification

Type II

Dosage Form

Tablet

Strength

Levonorgestrel : 150 ug
Ethinyl Estradiol : 30 ug

Lot Number

Lot C48054

Marketing Authorization Holder

Wyeth Canada
1025 Marcel-Laurin Boulevard
St-Laurent, Quebec
H4R 1J6

Reason for Recall

A blister of Min-Ovral 21 was found with one missing tablet.

Depth of Recall - Distribution

Wholesalers and pharmacies in Canada only. No export.

Top of Page

Trade Name

Min-Ovral 28

Recall Posting Date

2009-05-25

Recalling Firm

Wyeth Canada
1025 Marcel-Laurin Boulevard
St-Laurent, Quebec
H4R 1J6

Recall Start Date

2009-04-30

DIN, NPN, DIN-HM

DIN 02042339

Hazard Classification

Type III

Dosage Form

Tablets

Strength

Levonorgestrel : 150 ug
Ethinyl Estradiol : 30 ug

Lot Number

394794

Marketing Authorization Holder

Wyeth Canada
1025 Marcel-Laurin Boulevard
St-Laurent, Quebec
H4R 1J6

Reason for Recall

A blister of Min-Ovral 21 was found inside a carton of Min-Ovral 28.

Depth of Recall - Distribution

Wholesalers and pharmacies in Canada only. No export.

Top of Page

Trade Name

Mission Falls Premium Ionic Solution

Recall Posting Date

2009-04-27

Recalling Firm

Mission Falls Ionic Silver Solutions 34110 Lougheed Highway Mission, British Columbia V2V 5B9

Recall Start Date

2009-04-02

DIN, NPN, DIN-HM

None

Hazard Classification

Type II

Dosage Form

Solution, Spray, Liquid Drop Form

Strength

5 ppm

Lot Number

Solution - lots 1000101-100142 Spray - lots 1000101-100142 Drops - lots 1000136-1000142

Marketing Authorization Holder

N/A

Reason for Recall

Type II hazard - exceeds maximal oral Reference Dose for children and adults (as instructed for when ill), not evaluated for sterility as the Drops can be used on the eye, no NPN and no SL.

Depth of Recall - Distribution

Single channel distribution to Health Food Stores in British Columbia and Alberta.

Top of Page

Trade Name

Niaspan

Recall Posting Date

2009-05-25

Recalling Firm

Sepracor Pharmaceuticals, Inc.
6790 Century Avenue, Suite 100,
Mississauga, Ontario
L5N 2V8

Recall Start Date

2009-05-01

DIN, NPN, DIN-HM

DIN 02262339

Hazard Classification

Type III

Dosage Form

Tablets

Strength

1000 mg

Lot Number

7026541

Marketing Authorization Holder

Sepracor Pharmaceuticals, Inc.
6790 Century Avenue, Suite 100,
Mississauga, Ontario
L5N 2V8

Reason for Recall

Dissolution test out of specification at 18 month stability timepoint.

Depth of Recall - Distribution

Wholesalers across Canada.

Top of Page

Trade Name

Novo-Pramipexole 0.25 mg Tablets

Recall Posting Date

2009-05-11

Recalling Firm

Novopharm Limited 30 Novopharm Court Toronto, Ontario M1B 2K9

Recall Start Date

2009-04-17

DIN, NPN, DIN-HM

DIN 02269309

Hazard Classification

Type II

Dosage Form

Oral tablets

Strength

0.25 mg

Lot Number

Lot 35307585 Lot 35307586 Lot 35307591 Lot 35307593

Marketing Authorization Holder

Novopharm Limited 30 Novopharm Court Toronto, Ontario M1B 2K9

Reason for Recall

Product lots were found to be OOS for dissolution and / or content uniformity.

Depth of Recall - Distribution

Product is distributed to: British Columbia, Alberta, Saskatchewan, Ontario, Quebec, New Brunswick. Wholesalers distribute product to pharmacies, hospitals and nursing homes. Product is not exported.

Top of Page

Trade Name

PHSV Senna Lax 8.6MG NAT 100TB

Recall Posting Date

2009-04-27

Recalling Firm

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

Recall Start Date

2009-04-13

DIN, NPN, DIN-HM

NPN 02237105 (note: due to the DIN/NPN transitions, product may also be labelled with the DIN 02237105)

Hazard Classification

Type II

Dosage Form

Tablets

Strength

8.6 mg

Lot Number

PHSV Senna Lax 8.6MG NAT 100TB 6H11013RR, 7C120194W, 7C12117QY, 7G0101AAQ, 7G0101AJY, 7H0901CKE, 8A0251G5V, 8G0351HVQ, 8G0361HVQ, 8H0501KW0, 8H0501MB0, 8I0951MB0, 8J0241N80

Marketing Authorization Holder

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

Reason for Recall

The manufacturer initiated a class II voluntarily recall of the affected lots because they contain small amounts of undeclared anhydrous lactose and tartaric acid.

Depth of Recall - Distribution

Distributed across Canada.

Top of Page

Trade Name

pms-Gabapentin

Recall Posting Date

2009-04-13

Recalling Firm

Pharmascience 6111 Royalmount Avenue, Suite 100 Montreal, Quebec H4P 2T4

Recall Start Date

2009-03-26

DIN, NPN, DIN-HM

DIN 02243448

Hazard Classification

Type II

Dosage Form

Capsule

Strength

400 mg

Lot Number

440617, 440618, 439796

Marketing Authorization Holder

Pharmascience 6111 Royalmount Avenue, Suite 100 Montreal, Quebec H4P 2T4

Reason for Recall

These lots are being recalled due to an error in the colour of the capsules that are red instead of orange.

Depth of Recall - Distribution

Wholesalers and pharmacies in Canada only. No exportation.

Top of Page

Trade Name

pro-Gabapentin

Recall Posting Date

2009-04-13

Recalling Firm

Pro Doc Limited 2925 Industrial Boulevard Laval, Quebec H7L 3W9

Recall Start Date

2009-03-27

DIN, NPN, DIN-HM

DIN 02310465

Hazard Classification

Type II

Dosage Form

Capsule

Strength

400 mg

Lot Number

439797, 439798

Marketing Authorization Holder

Pro Doc Limited 2925 Industrial Boulevard Laval, Quebec H7L 3W9

Reason for Recall

These lots are being recalled due to an error in the colour of the capsules that are red instead of orange.

Depth of Recall - Distribution

Wholesalers and pharmacies in Canada only. No exportation.

Top of Page

Trade Name

ratio-Bisacodyl

Recall Posting Date

2009-05-25

Recalling Firm

ratiopharm
17800 Lapointe
Mirabel, Quebec
J7J 1P3

Recall Start Date

2009-04-30

DIN, NPN, DIN-HM

DIN 00404802

Hazard Classification

Type III

Dosage Form

Suppository

Strength

10 mg

Lot Number

643565

Marketing Authorization Holder

ratiopharm
17800 Lapointe
Mirabel, Quebec
J7J 1P3

Reason for Recall

This lot is being recalled because some of the suppositories containing the product ratio-Bisacodyl 10 mg may have been labelled with the product name ratio-Proctosone. Packaging box is correctly labelled.

Depth of Recall - Distribution

Wholesalers and pharmacies in Canada only. No exportation.

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Trade Name

Rhinaris Sinomarin

Recall Posting Date

2009-04-13

Recalling Firm

PendoPharm, Division of Pharmascience Inc. Importer 6111 Royalmount Avenue, Montreal, Quebec H4P 2T4

Recall Start Date

2009-03-31

DIN, NPN, DIN-HM

None

Hazard Classification

Type II

Dosage Form

Nasal wash

Strength

Hypertonic

Lot Number

Lot 07031, Lot 08033

Marketing Authorization Holder

N/A

Reason for Recall

Presence of bacteria at levels higher than the allowable limits in these 2 recalled lots.

Depth of Recall - Distribution

The product is distributed to wholesalers and drugstores in Canada. No exports.

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Trade Name

Rofact

Recall Posting Date

2009-05-25

Recalling Firm

Valeant Canada Limited
4787 Levy Street
Montreal, Quebec
H4R 2P9

Recall Start Date

2009-05-08

DIN, NPN, DIN-HM

DIN 00343617

Hazard Classification

Type I

Dosage Form

Capsule

Strength

300 mg

Lot Number

8K5467

Marketing Authorization Holder

Valeant Canada Limited
4787 Levy Street
Montreal, Quebec
H4R 2P9

Reason for Recall

This lot is being recalled because some bottles of Rofact may have been packaged/labeled with clonazepam.

Depth of Recall - Distribution

Wholesalers and pharmacies in Canada only. No exportation.

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Trade Name

Smoke51 & Filter Smoke51
(Smoke 51 Kit and Smoke 51 cartridges)

Recall Posting Date

2009-05-25

Recalling Firm

Kor Systems
5565 Glencrest
Cote St-Luc, Quebec
H4V 2L8

Recall Start Date

2009-04-19

DIN, NPN, DIN-HM

No MA

Hazard Classification

Unacceptable risk to health

Dosage Form

Electronic cigarettes & nicotine cartridges

Strength

For the cartridges: 4, 6 & 8 mg (nicotine)

Lot Number

Not applicable

Marketing Authorization Holder

N/A

Reason for Recall

This follows the determination by Health Canada that electronic cigarettes and cartridges of nicotine solution fall within the scope of the Food and Drugs Act and as such require a market authorization before they can be imported, advertised or sold in Canada. The sale of these health products is currently non compliant with the Food and Drugs Act since no electronic smoking products have been granted a market authorization in Canada.

Depth of Recall - Distribution

Smoke shops and drugstores in Quebec only. No exports.

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Trade Name

Senna S Tablets 60s and 10s / Preferred, Life Brand, Encounter, Safeway

Recall Posting Date

2009-05-11

Recalling Firm

Tanta Pharmaceuticals Inc., 1009 Burns Street East, Whitby, Ontario

Recall Start Date

2009-04-09

DIN, NPN, DIN-HM

DIN 02246951

Hazard Classification

Type III

Dosage Form

Tablet

Strength

Sennosides 8.6 mg and Docusate sodium 50 mg

Lot Number

K014U B045U G019U

Marketing Authorization Holder

Tanta Pharmaceuticals Inc., 1009 Burns Street East, Whitby, Ontario

Reason for Recall

These lots are mislabeled. The products contain lactose and tartaric acid which are not declared on the list of non medicinal ingredients on the product labels.

Depth of Recall - Distribution

Distributed to retail pharmacies, wholesalers and private label customers in Ontario, New Brunswick, Quebec, Alberta, Manitoba, Saskatchewan, Newfoundland and British Columbia.

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Trade Name

Senna Tablets 30s and 100s / Life Brand, Tanta, Preferred, Encounter

Recall Posting Date

2009-05-11

Recalling Firm

Tanta Pharmaceuticals Inc., 1009 Burns Street East, Whitby, Ontario

Recall Start Date

2009-04-09

DIN, NPN, DIN-HM

NPN # 01957392

Hazard Classification

Type III

Dosage Form

Tablet

Strength

8.6 mg

Lot Number

K056U C040U

Marketing Authorization Holder

Tanta Pharmaceuticals Inc., 1009 Burns Street East, Whitby, Ontario

Reason for Recall

These lots are mislabeled. The products contain lactose and tartaric acid which are not declared on the list of non medicinal ingredients on the product labels.

Depth of Recall - Distribution

Distributed to retail pharmacies, wholesalers and private label customers in Ontario, New Brunswick, Quebec, Alberta, Manitoba, Saskatchewan, Newfoundland and British Columbia.

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Trade Name

Sinequan

Recall Posting Date

2009-04-13

Recalling Firm

Erfa Canada 8250 Decarie Blvd, suite 110, Montreal, Quebec H4P 2P5

Recall Start Date

2009-03-27

DIN, NPN, DIN-HM

DIN 00400750

Hazard Classification

Type III

Dosage Form

Capsule

Strength

75 mg

Lot Number

(L)028023

Marketing Authorization Holder

Erfa Canada 8250 Decarie Blvd, suite 110, Montreal, Quebec H4P 2P5

Reason for Recall

Assay and dissolution slightly below the specifications.

Depth of Recall - Distribution

The product is sold in Canada only.

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Trade Name

Vaprox Hydrogen Peroxide Sterilant

Recall Posting Date

2009-05-25

Recalling Firm

Steris Canada
6280 Northwest Drive,
Mississauga, Ontario
L4V 1J7

Recall Start Date

2009-05-13

DIN, NPN, DIN-HM

DIN 02047616

Hazard Classification

Type III

Dosage Form

Liquid

Strength

35.00%

Lot Number

PE5G029B

Marketing Authorization Holder

Steris Canada
6280 Northwest Drive,
Mississauga, Ontario
L4V 1J7

Reason for Recall

One container of Vaprox has been affected. The non vented plugs that prevent Hydrogen Peroxide from venting gas out to the environment may have been used on limited number of containers which may result in unusual swelling of the container. Only one 5 gallon container was imported and is being recalled.

Depth of Recall - Distribution

Import only. One account in Quebec.

Trade Name

Recall Posting Date

Recalling Firm

Drug and Medical Device Recall Listings

Date Modified: 2009-12-16

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Important Notices