Recall Posting Date

2009/12/21

Trade Name

Apo-Diltiaz SR

Recalling Firm

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2009/11/30

DIN, NPN, DIN-HM

DIN 02222957

Hazard Classification

Type II

Dosage Form

Capsule

Strength

60 mg

Lot Number

All live batches
100's - HW1420, JA 4768
500's - HW1421, JA4769

Marketing Authorization Holder

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Routine stability monitoring detected excessive dissolution results on three batches. There were three previous stability failure cases for this product. All live batches currently on the market were tested for dissolution and some of the batches generated failing results.

Depth of Recall - Distribution

HW1420 - Canada & Bahamas HW1421 - Canada, no export
JA4768 - Canada & Oman, Palau JA4769 - Canada, no export

Recall Posting Date

2009/12/21

Trade Name

Apo-Diltiaz SR

Recalling Firm

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2009/11/30

DIN, NPN, DIN-HM

DIN 02222965

Hazard Classification

Type II

Dosage Form

Capsule

Strength

90 mg

Lot Number

All live batches
100's - HW1414, JA 4771, JE3129
500's - HW1412, JA4772

Marketing Authorization Holder

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Routine stability monitoring detected excessive dissolution results on three batches. There were three previous stability failure cases for this product. All live batches currently on the market were tested for dissolution and some of the batches generated failing results.

Depth of Recall - Distribution

HW1414 - Canada & Bahamas, Hong Kong HW1412 - Canada, no export
JA4771 - Canada & Bahamas, Hong Kong, Oman, Palau JA4772 - Canada & Palau
JE3129 - Canada & Hong Kong

Recall Posting Date

2009/12/21

Trade Name

Apo-Diltiaz SR

Recalling Firm

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2009/11/30

DIN, NPN, DIN-HM

DIN 02222973

Hazard Classification

Type II

Dosage Form

Capsule

Strength

120 mg

Lot Number

All live batches
100's - HT4754, HY4043, JA9740, JE3330
500's - HY4044, JA9741

Marketing Authorization Holder

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Routine stability monitoring detected excessive dissolution results on three batches. There were three previous stability failure cases for this product. All live batches currently on the market were tested for dissolution and some of the batches generated failing results.

Depth of Recall - Distribution

HT4754 - Canada & Hong Kong, Haiti HY4044 - Canada & Palau
HY4043 - Canada & Hong Kong JA9741 - Palau
JA9740 - Palau
JE3330 - Canada & Hong Kong

Recall Posting Date

2009/12/21

Trade Name

Apo-Fluconazole

Recalling Firm

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2009/11/30

DIN, NPN, DIN-HM

DIN 02241895

Hazard Classification

Type II

Dosage Form

Capsule

Strength

150 mg

Lot Number

HP8609

Marketing Authorization Holder

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Routine stability monitoring detected a maximum unknown impurity of 0.6%, the specification is 0.2%. Investigation determined that the impurity originated with an API from a particular supplier. That supplier is no longer being used. All batches that have been manufactured using API from that supplier have expired with the exception of the recalled batch.

Depth of Recall - Distribution

Canada, Bahamas, Hong Kong, Jamaica, El Salvador, Trinidad/Tobago

Recall Posting Date

2009/12/21

Trade Name

Apo-Levocarb CR

Recalling Firm

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2009/11/30

DIN, NPN, DIN-HM

DIN 02245211

Hazard Classification

Type II

Dosage Form

Tablets

Strength

Carbidopa - 50 mg
Levodopa - 200 mg

Lot Number

All live batches
100's - HN8694, HH8695, HN8696, HR7081, HR7083, HV1089, HV1096, HY7843, JA8415, JA8417, JC2860, JE3728, JE3729, JE3730, JF0050, JF0051

500's - HN8691, HN8692, HR7082, HV1091, JA8416, JA8418, JC6779, JE3732, JE3733, JF0049

Marketing Authorization Holder

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Routine stability monitoring detected failing dissolution results for four batches.

Depth of Recall - Distribution

Canada, Barbados (JC2860), Dominica (HV1089), United Arab Emirates (HV1096, HY7843, JA8415, HV1091)

Recall Posting Date

2009/12/21

Trade Name

Apo-Loperamide

Recalling Firm

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2009/11/30

DIN, NPN, DIN-HM

DIN 02212005

Hazard Classification

Type II

Dosage Form

Tablets

Strength

2 mg

Lot Number

(All batches packaged in blisters)
APO 18x10 - HW8106
LOB 6x4 LOB 6x7 LOB 6
HR1237 HR1175 HX6963
HW5603 HW5476 HX9525
JA8431 HX9499 JA8312
JD7481 JA8435
JF3951 JF3962
SDM 6x1 SDM 6x7 SDM 6x4 SDM 6x2
HR1176 HR1180 HR1191 HR1182
HW5316 HW5467 HT4472 HW5620
HX9504 HX9500 HW5596 HX9511
JA8445 HZ0825 HX9505 JA8326
JE2165 JA8327 JA8444 JD7480
JF3963 JD7478 JD7477 JF3965
JF3966 JF3967

Marketing Authorization Holder

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Routine stability monitoring detected OOS levels of a RC (oxidation product of loperamide that can increase significantly with exposure to air and high humidity). All batches that have been packaged in blisters are impacted.

Depth of Recall - Distribution

Apotex labelled product: Canada, Libya (JC6150, JA8446)

Recall Posting Date

2009/12/21

Trade Name

Apo-Loperamide

Recalling Firm

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2009/11/30

DIN, NPN, DIN-HM

DIN 02212005

Hazard Classification

Type II

Dosage Form

Tablets

Strength

2 mg

Lot Number

(All batches packaged in blisters) REX 6x4 REX 6x2 REX 6x1
HT4497 HT4489 HW5312
HW5307 HW5310 HX9509
HX9502 HX9507 JA8314
JA8322 JA8317 JE2164
JE2162 JE2163 JF3957
JF3954 JF3955
VDM 6x4 PDM 6x1 PHA 6
HR1177 JA8337 HR1236
HW5314 JD7474 HW5400
JA8336 HX9515
JE2160 JC5346
JF3950
SOB 6x2 SOB 6x4 APC 10x6 APC 6x24
HW5306 HR1178 HW8104 HW8105
HX9513 HW5305 JC6150 JX9521
JA8330 HX9514 JD7484 JA8446
JD7476 JA8335 JE5909
JF3958 JD7475
REM 12 REM 24
HZ7062 HZ7061

Marketing Authorization Holder

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Routine stability monitoring detected OOS levels of a RC (oxidation product of loperamide that can increase significantly with exposure to air and high humidity). All batches that have been packaged in blisters are impacted.

Depth of Recall - Distribution

Apotex labelled product: Canada, Libya (JC6150, JA8446)

Recall Posting Date

2009/12/21

Trade Name

Apo-Pen VK

Recalling Firm

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2009/11/30

DIN, NPN, DIN-HM

DIN 00642223

Hazard Classification

Type II

Dosage Form

Powder for solution

Strength

125 mg/5mL

Lot Number

HJ0595, HN 9751

Marketing Authorization Holder

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Routine stability monitoring detected assay failures (below specification).

Depth of Recall - Distribution

Canada, Antigua/Barbuda, Barbados, Bahamas, Belize, Fiji, Jamaica, Nicaragua

Recall Posting Date

2009/12/21

Trade Name

Apo-Pen VK

Recalling Firm

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Recall Start Date

2009/11/30

DIN, NPN, DIN-HM

DIN 00642231

Hazard Classification

Type II

Dosage Form

Powder for solution

Strength

300 mg/5mL

Lot Number

HF7253 HJ0597
HJ8448 HJ8456
HL3201 HM5684
HM7727 HN9756

Marketing Authorization Holder

Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9

Reason for Recall

Routine stability monitoring detected assay failures (below specification).

Depth of Recall - Distribution

Canada, Haiti (HF7253, HJ8448, HM7727, HN9756)

Recall Posting Date

2009/12/21

Trade Name

Mammicurine 880 Applicators

Recalling Firm

PHD Distribution International Inc.
261 Cutting St.
Coaticook, Quebec
J1A 2G2

Recall Start Date

2009/11/16

DIN, NPN, DIN-HM

No MAN

Hazard Classification

Type II

Dosage Form

Gel

Strength

Calendula 1 X 0,25 ml;
Solanum lycopersicum 1 X 0,25 ml;
Echinacea 4 C 0,04 ml;
Phytolacca 2 X 0,25 ml ;
Solidago 1 C 0,10 ml.

Lot Number

HB 04 05 08 B

Marketing Authorization Holder

N/A

Reason for Recall

Type II risk to animal health and Type III risk to human health. The product has not been assessed for its quality, safety and efficacy by Health Canada and the sale of such a product has not be authorized in Canada.

Depth of Recall - Distribution

Veterinary clinics in Quebec only. No exportation.

Recall Posting Date

2009/12/07

Trade Name

Elixir de nos grands-mères (for adults)

Recalling Firm

Lise B. Mailloux
86 Parent,
St-Liboire, Quebec,
J0H 1R0

Recall Start Date

2009/10/28

DIN, NPN, DIN-HM

No MAN

Hazard Classification

Unacceptable risk to health

Dosage Form

Elixir

Strength

Unknown

Lot Number

Unavailable

Marketing Authorization Holder

N/A

Reason for Recall

Products pose an unacceptable risk to health without evidence of GMP compliance.

Depth of Recall - Distribution

Retail stores in Quebec only. No exports.

Recall Posting Date

2009/12/07

Trade Name

Elixir de nos grands-mères children’s formula

Recalling Firm

Lise B. Mailloux
86 Parent,
St-Liboire, Quebec,
J0H 1R0

Recall Start Date

2009/10/28

DIN, NPN, DIN-HM

No MAN

Hazard Classification

Unacceptable risk to health

Dosage Form

Elixir

Strength

Unknown

Lot Number

Unavailable

Marketing Authorization Holder

N/A

Reason for Recall

Products pose an unacceptable risk to health without evidence of GMP compliance.

Depth of Recall - Distribution

Retail stores in Quebec only. No exports.

Recall Posting Date

2009/12/07

Trade Name

EXACT Brand Sleep Aid Extra Strength

Recalling Firm

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

Recall Start Date

2009/10/30

DIN, NPN, DIN-HM

DIN 02244203

Hazard Classification

Type III

Dosage Form

Soft gel Capsules

Strength

50 mg / Capsule

Lot Number

All lots containing 40 Soft gel Capsules

Marketing Authorization Holder

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

Reason for Recall

Diphenhydramine Hydrochloride 50 mg packaged in 40 soft gel Capsules intended for sale as sleep aid exceeds the packaging limit of 1-gram as required by the Sleep Aid - Labelling standard and are not authorized as per the current marketing authorization.

Depth of Recall - Distribution

Sleep Aid drug product marketed in Canada. Distributed to Loblaws and sold in Superstores as EXACT Brand.

Recall Posting Date

2009/12/07

Trade Name

Honey Allergy

Recalling Firm

Lise B. Mailloux
86 Parent,
St-Liboire, Quebec,
J0H 1R0

Recall Start Date

2009/10/28

DIN, NPN, DIN-HM

No MAN

Hazard Classification

Unacceptable risk to health

Dosage Form

Liquid

Strength

3ml of essential oils per 340g format. Unknown for other formats

Lot Number

Unavailable

Marketing Authorization Holder

N/A

Reason for Recall

Products pose an unacceptable risk to health without evidence of GMP compliance.

Depth of Recall - Distribution

Retail stores in Quebec only. No exports.

Recall Posting Date

2009/12/07

Trade Name

Honey Cayenne Pepper

Recalling Firm

Lise B. Mailloux
86 Parent,
St-Liboire, Quebec,
J0H 1R0

Recall Start Date

2009/10/28

DIN, NPN, DIN-HM

No MAN

Hazard Classification

Unacceptable risk to health

Dosage Form

Liquid

Strength

Unknown

Lot Number

Unavailable

Marketing Authorization Holder

N/A

Reason for Recall

Products pose an unacceptable risk to health without evidence of GMP compliance.

Depth of Recall - Distribution

Retail stores in Quebec only. No exports.

Recall Posting Date

2009/12/07

Trade Name

Honey Constipation

Recalling Firm

Lise B. Mailloux
86 Parent,
St-Liboire, Quebec,
J0H 1R0

Recall Start Date

2009/10/28

DIN, NPN, DIN-HM

No MAN

Hazard Classification

Unacceptable risk to health

Dosage Form

Liquid

Strength

Unknown

Lot Number

Unavailable

Marketing Authorization Holder

N/A

Reason for Recall

Products pose an unacceptable risk to health without evidence of GMP compliance.

Depth of Recall - Distribution

Retail stores in Quebec only. No exports.

Recall Posting Date

2009/12/07

Trade Name

Honey Digestion

Recalling Firm

Lise B. Mailloux
86 Parent,
St-Liboire, Quebec,
J0H 1R0

Recall Start Date

2009/10/28

DIN, NPN, DIN-HM

No MAN

Hazard Classification

Unacceptable risk to health

Dosage Form

Liquid

Strength

Unknown

Lot Number

Unavailable

Marketing Authorization Holder

N/A

Reason for Recall

Products pose an unacceptable risk to health without evidence of GMP compliance.

Depth of Recall - Distribution

Retail stores in Quebec only. No exports.

Recall Posting Date

2009/12/07

Trade Name

Honey Eucalyptus

Recalling Firm

Lise B. Mailloux
86 Parent,
St-Liboire, Quebec,
J0H 1R0

Recall Start Date

2009/10/28

DIN, NPN, DIN-HM

No MAN

Hazard Classification

Unacceptable risk to health

Dosage Form

Liquid

Strength

1.5ml of eucalyptus oil per 340g format. Unknown for other formats

Lot Number

Unavailable

Marketing Authorization Holder

N/A

Reason for Recall

Products pose an unacceptable risk to health without evidence of GMP compliance.

Depth of Recall - Distribution

Retail stores in Quebec only. No exports.

Recall Posting Date

2009/12/07

Trade Name

Honey Flu-fighter

Recalling Firm

Lise B. Mailloux
86 Parent,
St-Liboire, Quebec,
J0H 1R0

Recall Start Date

2009/10/28

DIN, NPN, DIN-HM

No MAN

Hazard Classification

Unacceptable risk to health

Dosage Form

Liquid

Strength

3ml of essential oils per 340g format. Unknown for other formats

Lot Number

Unavailable

Marketing Authorization Holder

N/A

Reason for Recall

Products pose an unacceptable risk to health without evidence of GMP compliance.

Depth of Recall - Distribution

Retail stores in Quebec only. No exports.

Recall Posting Date

2009/12/07

Trade Name

Honey Relaxation

Recalling Firm

Lise B. Mailloux
86 Parent,
St-Liboire, Quebec,
J0H 1R0

Recall Start Date

2009/10/28

DIN, NPN, DIN-HM

No MAN

Hazard Classification

Unacceptable risk to health

Dosage Form

Liquid

Strength

3ml of essential oils per 340g format. Unknown for other formats

Lot Number

Unavailable

Marketing Authorization Holder

N/A

Reason for Recall

Products pose an unacceptable risk to health without evidence of GMP compliance.

Depth of Recall - Distribution

Retail stores in Quebec only. No exports.

Recall Posting Date

2009/12/07

Trade Name

Honey Sinusitis

Recalling Firm

Lise B. Mailloux
86 Parent,
St-Liboire, Quebec,
J0H 1R0

Recall Start Date

2009/10/28

DIN, NPN, DIN-HM

No MAN

Hazard Classification

Unacceptable risk to health

Dosage Form

Liquid

Strength

3ml of essential oils per 340g format. Unknown for other formats

Lot Number

Unavailable

Marketing Authorization Holder

N/A

Reason for Recall

Products pose an unacceptable risk to health without evidence of GMP compliance.

Depth of Recall - Distribution

Retail stores in Quebec only. No exports.

Recall Posting Date

2009/12/07

Trade Name

Honey Snoring Reducer

Recalling Firm

Lise B. Mailloux
86 Parent,
St-Liboire, Quebec,
J0H 1R0

Recall Start Date

2009/10/28

DIN, NPN, DIN-HM

No MAN

Hazard Classification

Unacceptable risk to health

Dosage Form

Liquid

Strength

Unknown

Lot Number

Unavailable

Marketing Authorization Holder

N/A

Reason for Recall

Products pose an unacceptable risk to health without evidence of GMP compliance.

Depth of Recall - Distribution

Retail stores in Quebec only. No exports.

Recall Posting Date

2009/12/07

Trade Name

LIFE Brand Extra Strength Sleep Aid
EXACT Brand Extra Strength Sleep Aid

Recalling Firm

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

Recall Start Date

2009/10/30

DIN, NPN, DIN-HM

DIN 02230485

Hazard Classification

Type III

Dosage Form

Tablets

Strength

50 mg / Tablet

Lot Number

All lots containing 40 Tablets

Marketing Authorization Holder

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

Reason for Recall

Diphenhydramine Hydrochloride 50 mg packaged in 40 soft gel Capsules intended for sale as sleep aid exceeds the packaging limit of 1-gram as required by the Sleep Aid - Labelling standard and are not authorized as per the current marketing authorization.

Depth of Recall - Distribution

Sleep Aid drug product marketed in Canada. Distributed to Loblaws and sold in Superstores as EXACT Brand.

Recall Posting Date

2009/12/07

Trade Name

ratio-Salbutamol HFA

Recalling Firm

ratiopharm
17800 Lapointe
Mirabel, Quebec
J7J 1P3

Recall Start Date

2009/11/09

DIN, NPN, DIN-HM

DIN 02244914

Hazard Classification

Type III

Dosage Form

Aerosol

Strength

100 mcg

Lot Number

5410

Marketing Authorization Holder

ratiopharm
17800 Lapointe
Mirabel, Quebec
J7J 1P3

Reason for Recall

Out of specification stability results for particule size distribution have been reported for lot 5410.

Depth of Recall - Distribution

Wholesalers and pharmacies in Canada only. No exportation.

Recall Posting Date

2009/12/07

Trade Name

Sodium Iodide I - 123

Recalling Firm

MDS Nordion
4004 Wesbrook Mall
Vancouver, British Columbia

Recall Start Date

2009/11/09

DIN, NPN, DIN-HM

Not Required

Hazard Classification

Type III

Dosage Form

Oral Solution

Strength

2 mCi / 74 mBq (25 mCi/mL)

Lot Number

OS-09-149

Marketing Authorization Holder

MDS Nordion
4004 Wesbrook Mall
Vancouver, British Columbia

Reason for Recall

On November 9, 2009, MDS Nordion identified an error on the Certificate of Compliance that accompanied shipments of Sodium Iodide I-123 Oral Solution Lot OS-09-149. The Calibration Date and Expiry Date, 05-Nov-2009 and 06-Nov-2009 respectively were incorrectly printed as 05-Nov200 and 06-Nov-200. The information on the product label affixed to the lead pot was correct.

Depth of Recall - Distribution

Distributed to 5 Hospital Sites; 4 hospitals in British Columbia and 1 in Quebec.

Recall Posting Date

2009/12/07

Trade Name

Zaditen (1 mg/Tablet)

Recalling Firm

Paladin Labs Inc.
6111 Royalmount Ave., suite 102
Montreal, Quebec
H4P 2T4

Recall Start Date

2009/11/20

DIN, NPN, DIN-HM

DIN 00577308

Hazard Classification

Type II

Dosage Form

Tablets

Strength

1 mg/Tablet

Lot Number

440494

Marketing Authorization Holder

Paladin Labs Inc.
6111 Royalmount Ave., suite 102
Montreal, Quebec
H4P 2T4

Reason for Recall

Zaditen is a prophylactic treatment for asthmatic children. The assay result for ketotifen active ingredient in Zaditen 1 mg tablets (lot 440494) is out of specification (OOS) 6 months after the release. The allowed range of ketotifen fumarate is 90 - 110%, however the laboratory test demonstrated only 78%.

Depth of Recall - Distribution

Wholesalers and pharmacies

Recall Posting Date

2009/11/23

Trade Name

3V Caps Snip Tips

Recalling Firm

Novopharm
30 Novopharm Court
Toronto, Ontario
M1B 2K9

Recall Start Date

2009/10/26

DIN, NPN, DIN-HM

No Market Authorization

Hazard Classification

Type II

Dosage Form

Snip Caps

Strength

3V Snip Caps 270 mg
Eicosapentaenoic Acid (EPA) 270 mg
Docosahexanoic Acid (DHA) 175 mg
D-alpha Tocoferol (Vitmin E) 1.5 IU

3V Snip Caps 540 mg
Eicosapentaenoic Acid (EPA) 540 mg
Docosahexanoic Acid (DHA) 350 mg
D-alpha Tocoferol (Vitmin E) 3 IU

Lot Number

Snip Caps 270 mg

1. D7165A
2. H7103A
3. D8313A
4. I8040A
5. A9254A

Snip Caps 540 mg

1. J7116A
2. H7100A
3. J8268A
4. H8107A

Marketing Authorization Holder

N/A

Reason for Recall

FDA Consent Decree of Teva Animal Health

Depth of Recall - Distribution

Wholesale

Recall Posting Date

2009/11/23

Trade Name

Chaotic Drinks - Elixir of Tenacity

Recalling Firm

U and Me Marketing Inc.
460 Brant Street
Burlington, Ontario
L7R 4B6

Recall Start Date

2009/10/24

DIN, NPN, DIN-HM

No Market Authorization

Hazard Classification

Type II

Dosage Form

Liquid

Strength

Vitamin A - 3750 IU/ 1126ug RAE
Vitamin E - 23 IU / 15.4mg AT
Vitamin C - 60mg
Green Tea Extract - 105mg

Lot Number

031010KF, 06111KF

Marketing Authorization Holder

N/A

Reason for Recall

Unauthorized natural health product that is clearly marketed and indicated for use by children and is therefore subject to the risk-based approach to compliance in accordance with the Compliance Policy for Natural Health Products.

Depth of Recall - Distribution

Wholesalers and retail

Recall Posting Date

2009/11/23

Trade Name

Chaotic Drinks - Fearocity

Recalling Firm

U and Me Marketing Inc.
460 Brant Street
Burlington, Ontario
L7R 4B6

Recall Start Date

2009/10/24

DIN, NPN, DIN-HM

No Market Authorization

Hazard Classification

Type II

Dosage Form

Liquid

Strength

Green tea extract - 105mg
Guarana (paullinia cupana - seed extract) - 150 mg
Eleutherococcus senticosus root extract - 75mg Yerba mate (llex paraguariensis leaf extract) - 37.5mg
Niacin - 30 gm
Panax ginseng root extract - 75mg
Pantothenic acid - 15mg
Vitamin B6 - 3mg
Vitamin B12 cyanobalamin - 9 mcg

Lot Number

031010KF, 061110KF

Marketing Authorization Holder

N/A

Reason for Recall

Unauthorized natural health product that is clearly marketed and indicated for use by children and is therefore subject to the risk-based approach to compliance in accordance with the Compliance Policy for Natural Health Products.

Depth of Recall - Distribution

Wholesalers and retail

Recall Posting Date

2009/11/23

Trade Name

Chaotic Drinks - Mind Strike

Recalling Firm

U and Me Marketing Inc.
460 Brant Street
Burlington, Ontario
L7R 4B6

Recall Start Date

2009/10/24

DIN, NPN, DIN-HM

No Market Authorization

Hazard Classification

Type II

Dosage Form

Liquid

Strength

Green tea extract - 105mg
Gotu Kola (hyrocotyle asiatica leaf extract ) - 79mg
Vitamin B6 - 1.68mg
Choline Bitartrate - 30mg

Lot Number

031010KF, 061110KF

Marketing Authorization Holder

N/A

Reason for Recall

Unauthorized natural health product that is clearly marketed and indicated for use by children and is therefore subject to the risk-based approach to compliance in accordance with the Compliance Policy for Natural Health Products.

Depth of Recall - Distribution

Wholesalers and retail

Recall Posting Date

2009/11/23

Trade Name

Chaotic Drinks - Power Pulse

Recalling Firm

U and Me Marketing Inc.
460 Brant Street
Burlington, Ontario
L7R 4B6

Recall Start Date

2009/10/24

DIN, NPN, DIN-HM

No Market Authorization

Hazard Classification

Type II

Dosage Form

Liquid

Strength

Calcium malate - 150mg
Magnesium lactate - 60 mg
Vitamin D -150 IU / 3.75 ug cholecalciferol
Arginine - 37.5 mg
Zinc picolinate - 2mg
Chromium picolinate - 42mg

Lot Number

031010KF, 061110KF

Marketing Authorization Holder

N/A

Reason for Recall

Unauthorized natural health product that is clearly marketed and indicated for use by children and is therefore subject to the risk-based approach to compliance in accordance with the Compliance Policy for Natural Health Products.

Depth of Recall - Distribution

Wholesalers and retail

Recall Posting Date

2009/11/23

Trade Name

Derm Caps Liquid 177 ml

Recalling Firm

Novopharm
30 Novopharm Court
Toronto, Ontario
M1B 2K9

Recall Start Date

2009/10/26

DIN, NPN, DIN-HM

No Market Authorization

Hazard Classification

Type II

Dosage Form

Liquid

Strength

Linoleic Acid (LA) 49.5%
Eicosapentaenoic Acid (EPA) 4.2%
Docosahexaenoic Acid (DHA) 2.8%
Gamma Linolenic Acid (GLA) 1.6%
Vitamin E 35 IU

Lot Number

1.L164171
2.L028181
3.L197181
4.903020A

Marketing Authorization Holder

N/A

Reason for Recall

FDA Consent Decree of Teva Animal Health

Depth of Recall - Distribution

Wholesale

Recall Posting Date

2009/11/23

Trade Name

Derm Caps RS
Derm Caps ES

Recalling Firm

Novopharm
30 Novopharm Court
Toronto, Ontario
M1B 2K9

Recall Start Date

2009/10/26

DIN, NPN, DIN-HM

No Market Authorization

Hazard Classification

Type II

Dosage Form

645 & 945 mg capsules

Strength

Derma Caps Regular Strength 645 mg capsules

Linoleic Acid (LA) 45.4%
Elcosapentaenoic Acid (EPA) 3.9%
Dosocahexaenoic Acid (DHA) 2.6%
Gamma Linolenic Acid (GLA) 1.2%
Vitamin E 75 IU

Derma Caps Extra Strength 945 mg capsules

Linoleic Acid (LA) 29.8%
Elcosapentaenoic Acid (EPA) 8.0%
Dosocahexaenoic Acid (DHA) 5.3%
Gamma Linolenic Acid (GLA) 2.1%
Vitamin E 75 IU

Lot Number

Derm Caps Regular Strength
1. 16006240
2. 160073621
3. 160059361

Derm Caps Extra Strength
1.160059331
2. 160073582
3. 160064831
4. 160073583

Marketing Authorization Holder

N/A

Reason for Recall

FDA Consent Decree of Teva Animal Health

Depth of Recall - Distribution

Wholesale

Recall Posting Date

2009/11/23

Trade Name

Formo Cresol Liq

Recalling Firm

VDI Healthcare
250 First Gulf Blvd.
Brampton, Ontario
L6W 4T5

Recall Start Date

2009/10/12

DIN, NPN, DIN-HM

NPN 00470236

Hazard Classification

Type III

Dosage Form

Liquid

Strength

48.5 % w/w - Cresol
48.5% w/w - formaldehyde

Lot Number

110925952 & 0710080703

Marketing Authorization Holder

Sultan Healthcare
411 Hackensack Ave.
Hackensack, New Jersey
07601, USA

Reason for Recall

Failed stability for percent cresol and formaldehyde content at 24-month shelf life.

Depth of Recall - Distribution

Dentist Offices

Recall Posting Date

2009/11/23

Trade Name

Gastri Calm Chewable Tablets

Recalling Firm

Novopharm
30 Novopharm Court
Toronto, Ontario
M1B 2K9

Recall Start Date

2009/10/26

DIN, NPN, DIN-HM

No Market Authorization

Hazard Classification

Type II

Dosage Form

Chewable tablets

Strength

Zinc Carnosine 30 mg
Alpha Tocopheryl Acetate (Vit E) 30 IU

Lot Number

Gastri Calm Chewable Tablets 60 tablets per bottle
1. 801041
2. 804011
3. 805881

Gastri Calm Chewable tablets 120 tablets per bottle
1. 801051
2. 804021

Marketing Authorization Holder

N/A

Reason for Recall

FDA Consent Decree of Teva Animal Health

Depth of Recall - Distribution

Wholesale

Recall Posting Date

2009/11/23

Trade Name

OtiCalm Ear solution 118 ml and 355 ml bottles

Recalling Firm

Novopharm
30 Novopharm Court
Toronto, Ontario
M1B 2K9

Recall Start Date

2009/10/26

DIN, NPN, DIN-HM

No Market Authorization

Hazard Classification

Type II

Dosage Form

Solution

Strength

N/A

Lot Number

OtiCalm Ear Solution 118 ml
1.701101A
2. 801210B
3. 805150B
4. 801201A
5. 906120A

OtiCalm Ear Solution 355ml
1. 709011A
2. 801210A
3. 801240B
4. 809180B
5. 808201A
6. 906120B

Marketing Authorization Holder

N/A

Reason for Recall

FDA Consent Decree of Teva Animal Health

Depth of Recall - Distribution

Wholesale

Recall Posting Date

2009/11/23

Trade Name

Synovi G3 Soft Chew

Recalling Firm

Novopharm
30 Novopharm Court
Toronto, Ontario
M1B 2K9

Recall Start Date

2009/10/26

DIN, NPN, DIN-HM

No Market Authorization

Hazard Classification

Type II

Dosage Form

Soft chew tablets

Strength

Glucosamine HCl 450 mg
Methylsulfonylmethane (MSM) 400mg
Creatine Monohydrate 250 mg
Perna Canaliculus 150 mg
Eicosapentaenoic Acid (EPA) 9 mg
Docosahexaenoic Acid (DHA) 6mg
Alpha Tocopheryl Acetate (Vitamin E) 25IU
Ascorbic Acid (Vitamin C) 5mg

Lot Number

Synovi G3 Bottle of 120 tablets
1.703361
2. 901441
3.808011
4.804191
5.804001

Synovi G3 Bottle of 240 tablets
1. 703371
2. 711541
3. 805851
4. 808021
5. 901451

Marketing Authorization Holder

N/A

Reason for Recall

FDA Consent Decree of Teva Animal Health

Depth of Recall - Distribution

Wholesale

Recall Posting Date

2009/11/23

Trade Name

T8 Solution Ear Rinse 118 ml and 355 ml

Recalling Firm

Novopharm
30 Novopharm Court
Toronto, Ontario
M1B 2K9

Recall Start Date

2009/10/26

DIN, NPN, DIN-HM

No Market Authorization

Hazard Classification

Type II

Dosage Form

Solution

Strength

N/A

Lot Number

T8 Solution Ear Rinse 118 ml
1.8020140
2.8080601

T8 Solution Ear Rinse 355 ml
1.8020140

Marketing Authorization Holder

N/A

Reason for Recall

FDA Consent Decree of Teva Animal Health

Depth of Recall - Distribution

Wholesale

Recall Posting Date

2009/11/09

Trade Name

Cesamet 1 mg

Recalling Firm

Valeant Canada Ltd
4787 Levy,
Montreal, Quebec
H4R 2P9

Recall Start Date

2009/10/16

DIN, NPN, DIN-HM

DIN 00548375

Hazard Classification

Type I

Dosage Form

Capsule

Strength

1 mg

Lot Number

9D9875, 9E0077, 9G0282, 9G0283, 9G0362

Marketing Authorization Holder

Valeant Canada Ltd
4787 Levy,
Montreal, Quebec
H4R 2P9

Reason for Recall

Valeant Canada Ltd is recalling two products Cesamet 1 mg and Trazorel 50 mg because of a potential mislabel. There is a possibility that a bottle containing Cesamet Capsules 1mg be labelled as Trazorel Tablets 50mg. The Trazorel labelled bottle would bear one of the lot numbers and expiry dates mentioned above.

Depth of Recall - Distribution

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

Recall Posting Date

2009/11/09

Trade Name

Dexedrine Spansule SRC 10 mg

Recalling Firm

GlaxoSmithKline
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4

Recall Start Date

2009/10/20

DIN, NPN, DIN-HM

DIN 01924559

Hazard Classification

Type III

Dosage Form

Capsule (Sustained Release)

Strength

10 mg ( 100 count bottle)

Lot Number

0800801A

Marketing Authorization Holder

Paladin Laboratories
100 Alexis Nihon, Suite 600
Ville St-Laurent, Quebec
H4M 2P2

Reason for Recall

Out of Specification result obtained at the 12 month timepoint of stability testing. The OOS was confirmed for dissolution testing at 4 hours. The 4 hour test limits are 65-90% and the confirmed result was determined to be 62% at 4 hours.

Depth of Recall - Distribution

Product was sold and distributed throughout Canada.

Recall Posting Date

2009/11/09

Trade Name

Dihydroergotamine mesylate injectable USP 1 mg/ml

Recalling Firm

Sandoz Canada Inc.
145 Jules Leger,
Boucherville, Quebec
J4B 3K6

Recall Start Date

200910-15

DIN, NPN, DIN-HM

DIN 02241163

Hazard Classification

Type III

Dosage Form

liquid

Strength

1mg/ml

Lot Number

(L) 136632
(L) 140279
(L) 144827
(L) 148596
(L) 150796

Marketing Authorization Holder

Sandoz Canada Inc.
145 Jules Leger,
Boucherville, Quebec
J4B 3K6

Reason for Recall

Certain results from routine stability program indicate that the mentioned lots may not support their respective expiration date.

Depth of Recall - Distribution

Wholesalers and hospitals in Canada only.

Recall Posting Date

2009/11/09

Trade Name

Propofol

Recalling Firm

Hospira Healthcare Corporation
1111 Dr. Frederik Philips, suite 600
Saint-Laurent, Quebec
H4M 2X6

Recall Start Date

2009/10/14

DIN, NPN, DIN-HM

DIN 02236887

Hazard Classification

Type I

Dosage Form

Injectable emulsion

Strength

10 mg/ml

Lot Number

79883DJ
79834DJ

Marketing Authorization Holder

Hospira Healthcare Corporation
1111 Dr. Frederik Philips, suite 600
Saint-Laurent, Quebec
H4M 2X6

Reason for Recall

Presence of metallic particles.

Depth of Recall - Distribution

Hospital

Recall Posting Date

2009/11/09

Trade Name

RESFLOR Injection 100mL

Recalling Firm

Intervet Canada Corp.
16750 Trans Canada Highway
Kirkland, Quebec
H9H 4M7

Recall Start Date

2009/10/09

DIN, NPN, DIN-HM

DIN 02330997

Hazard Classification

Type II

Dosage Form

Injectable Solution

Strength

Florfenicol 300 mg
Flunixin (Flunixin meglumine) 16.5 mg

Lot Number

9656101

Marketing Authorization Holder

Intervet Canada Corp.
16750 Trans Canada Highway
Kirkland, Quebec
H9H 4M7

Reason for Recall

Error on the expiry date on the inner and outer labels and the delivery package of the product.

Depth of Recall - Distribution

7 customers (wholesalers, distributors and retails) no exportation.

Recall Posting Date

2009/11/09

Trade Name

Trazorel 50 mg

Recalling Firm

Valeant Canada Ltd
4787 Levy,
Montreal, Quebec
H4R 2P9

Recall Start Date

2009/10/16

DIN, NPN, DIN-HM

DIN 02230284

Hazard Classification

Type I

Dosage Form

Tablet

Strength

50 mg

Lot Number

9D9875, 9E0077, 9G0282, 9G0283, 9G0362

Marketing Authorization Holder

Valeant Canada Ltd
4787 Levy,
Montreal, Quebec
H4R 2P9

Reason for Recall

Valeant Canada Ltd is recalling two products Cesamet 1 mg and Trazorel 50 mg because of a potential mislabel. There is a possibility that a bottle containing Cesamet Capsules 1mg be labelled as Trazorel Tablets 50mg. The Trazorel labelled bottle would bear one of the lot numbers and expiry dates mentioned above.

Depth of Recall - Distribution

Trazorel 50 mg is distributed to 3 wholesalers in Saskatchewan only. No exports.

Recall Posting Date

2009/10/26

Trade Name

Penicillin G Procaine 300,000 IU

Recalling Firm

Novopharm
30 Novopharm Court
Toronto, Ontario
M1B 2K9

Recall Start Date

2009/10/05

DIN, NPN, DIN-HM

DIN 02300745

Hazard Classification

Type II

Dosage Form

Injections for veterinary use.

Strength

300,000 IU

Lot Number

1. BL710122
2. BL804043
3. BL709120
4. BL 803016
5. BL 71037

Marketing Authorization Holder

Novopharm
30 Novopharm Court
Toronto, Ontario
M1B 2K9

Reason for Recall

FDA Consent Decree of Teva Animal Health

Depth of Recall - Distribution

Wholesale

Recall Posting Date

2009/10/26

Trade Name

Tylenol Cold Rapid Release Gelcap Daytime / Nighttime

Recalling Firm

Johnson & Johnson Inc., Canada
88 McNabb St.
Markham, Ontario
L3R 5L2

Recall Start Date

2009/09/29

DIN, NPN, DIN-HM

DIN 02322838

Hazard Classification

Type II

Dosage Form

Gelcaps

Strength

Phenylephrine Hydrochloride - 5 mg
Chlorpheniramine Maleate - 2 mg
Acetaminophen - 325 mg
Dextromethorphan Hydrobromide - 10 mg

Lot Number

(L) 087C

Marketing Authorization Holder

Johnson & Johnson Inc., Canada
88 McNabb St.
Markham, Ontario
L3R 5L2

Reason for Recall

Labelling error on the blister card. The nighttime blister card reads “Gélules pour le jour” instead of “Gélules pour la nuit”.

Depth of Recall - Distribution

Wholesalers, distributors, retailers. Product is not exported.

Recall Posting Date

2009/10/12

Trade Name

Enbrel SureClick Autoinjector

Recalling Firm

Amgen Canada Inc.
6775 Financial Drive, Suite 100
Mississauga, Ontario
L5N 0A4

Recall Start Date

2009/09/18

DIN, NPN, DIN-HM

DIN 02274728

Hazard Classification

Type III

Dosage Form

Sterile liquid for injection

Strength

50 mg/ml etanercept (0.98 ml)

Lot Number

P116001, 1007162, 1006426, 1006776, 1009205, 1011782, 1013463, 1005289, 1008490, 1011790

Marketing Authorization Holder

Amgen Canada Inc.
6775 Financial Drive, Suite 100
Mississauga, Ontario
L5N 0A4

Reason for Recall

Potential syringe breakage within the autoinjector.

Depth of Recall - Distribution

Wholesalers in Canada only.

Recall Posting Date

2009/10/12

Trade Name

Intramammary Gel / MammiVet Gel Intramammaire

Recalling Firm

Distributor : Distripharm Inc.
1440 Hocquart, suite 104
St-Bruno, Quebec
J3V 6E1

Recall Start Date

2009/09/14

DIN, NPN, DIN-HM

None

Hazard Classification

Type II

Dosage Form

Gel

Strength

Asa foetida 4 CH, 0, 50 ML
Calendula officinalis 1 DH, 0, 80 ml
Echinacea augustifolia 1 DH, 0,80 ml
Phytolacca decandra 3 DH, 0,80 ml
Galega officinalis 1DH, 0, 50 ml

Lot Number

Lots : 8K2301, 8M0502, 9E1201

Marketing Authorization Holder

N/A

Reason for Recall

Type II risk to animal health and Type III risk to human health. The product has no market authorization (DIN).

Depth of Recall - Distribution

One veterinary pharmacy and clinics in Quebec only. No exportation.

Recall Posting Date

2009/10/12

Trade Name

K-Citra

Recalling Firm

Seaford Pharmaceuticals Inc.
1530 Drew Road, Unit 28
Mississauga, Ontario
L5S 1W8

Recall Start Date

2009/09/04

DIN, NPN, DIN-HM

NPN 80011529

Hazard Classification

Type III

Dosage Form

Solution

Strength

50 & 450 mL

Lot Number

(L)H2971, (L) I2071

Marketing Authorization Holder

Seaford Pharmaceuticals Inc.
1530 Drew Road, Unit 28
Mississauga, Ontario
L5S 1W8

Reason for Recall

The reason for the recall is that based on the preservative challenge test there was significant growth of yeast and mold when the product was exposed. However, the recalled lots were tested for Microbial contamination and found to be well within USP limits. The recall is based solely on the preservative challenge test.

Depth of Recall - Distribution

Two Wholesalers and 1 Pharmacy. No exports.