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Drugs and Health Products
Drug Recall Listings - Sorted by Recalling Firm
(From April 2009 - June 2009)
- Recalling Firm
- Apotex Inc.
150 Signet Drive,
Toronto, Ontario
M9L 1T9 - Recall Posting Date
- 2009-06-22
- Recall Start Date
- 2009-05-19
- Trade Name
- Apo-Lithium Carbonate SR
- 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. .
- Recalling Firm
- Apotex Inc. 150 Signet Drive, Toronto, Ontario M9L 1T9
- Recall Posting Date
- 2009-04-27
- Recall Start Date
- 2009-04-09
- Trade Name
- Apo-Clindamycin 300 mg
- 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.
- Recalling Firm
- Apotex Inc. 150 Signet Drive, Toronto, Ontario M9L 1T9
- Recall Posting Date
- 2009-04-27
- Recall Start Date
- 2009-04-09
- Trade Name
- Apo-Clindamycin 150 mg
- 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.
- Recalling Firm
- Dominion Pharmacal 6111 Royalmount Avenue, Suite 100 Montreal, Quebec H4P 2T4
- Recall Posting Date
- 2009-04-13
- Recall Start Date
- 2009-03-26
- Trade Name
- dom-Gabapentin
- 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.
- Recalling Firm
- Erfa Canada 8250 Decarie Blvd, suite 110, Montreal, Quebec H4P 2P5
- Recall Posting Date
- 2009-04-13
- Recall Start Date
- 2009-03-27
- Trade Name
- Sinequan
- 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.
- Recalling Firm
- Ferring Inc. 200 Yorkland Boulevard, Suite 800 North York, Ontario M2J 5C1
- Recall Posting Date
- 2009-04-13
- Recall Start Date
- 2009-03-19
- Trade Name
- Duratocin
- 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.
- Recalling Firm
- Kor Systems
5565 Glencrest
Cote St-Luc, Quebec
H4V 2L8 - Recall Posting Date
- 2009-05-25
- Recall Start Date
- 2009-04-19
- Trade Name
- Smoke51 & Filter Smoke51
(Smoke 51 Kit and Smoke 51 cartridges) - 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.
- Recalling Firm
- Mission Falls Ionic Silver Solutions 34110 Lougheed Highway Mission, British Columbia V2V 5B9
- Recall Posting Date
- 2009-04-27
- Recall Start Date
- 2009-04-02
- Trade Name
- Mission Falls Premium Ionic Solution
- 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.
- Recalling Firm
- Neolab Inc. (Distributor)
5476 Upper Lachine Road
Montreal, Quebec
H4A 2A4 - Recall Posting Date
- 2009-06-22
- Recall Start Date
- 2009-05-14
- Trade Name
- Dermaflex HC 1% Cream / Crème
- 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.
- Recalling Firm
- Neolab Inc. (Distributor)
5476 Upper Lachine Road
Montreal, Quebec
H4A 2A4 - Recall Posting Date
- 2009-06-22
- Recall Start Date
- 2009-05-14
- Trade Name
- Dermaflex HC 1% Lotion
- 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.
- Recalling Firm
- Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9 - Recall Posting Date
- 2009-06-08
- Recall Start Date
- 2009-05-15
- Trade Name
- Dobutamine Hydrochloride Injection
- 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.
- Recalling Firm
- Novopharm Limited 30 Novopharm Court Toronto, Ontario M1B 2K9
- Recall Posting Date
- 2009-05-11
- Recall Start Date
- 2009-04-17
- Trade Name
- Novo-Pramipexole 0.25 mg Tablets
- 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.
- Recalling Firm
- Novopharm Limited 30 Novopharm Court Toronto, Ontario M1B 2K9
- Recall Posting Date
- 2009-04-13
- Recall Start Date
- 2009-03-26
- Trade Name
- Irinotecan for Injection
- 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.
- Recalling Firm
- PendoPharm, Division of Pharmascience Inc. Importer 6111 Royalmount Avenue, Montreal, Quebec H4P 2T4
- Recall Posting Date
- 2009-04-13
- Recall Start Date
- 2009-03-31
- Trade Name
- Rhinaris Sinomarin
- 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.
- Recalling Firm
- Pharmascience 6111 Royalmount Avenue, Suite 100 Montreal, Quebec H4P 2T4
- Recall Posting Date
- 2009-04-13
- Recall Start Date
- 2009-03-26
- Trade Name
- pms-Gabapentin
- 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.
- Recalling Firm
- Pro Doc Limited 2925 Industrial Boulevard Laval, Quebec H7L 3W9
- Recall Posting Date
- 2009-04-13
- Recall Start Date
- 2009-03-27
- Trade Name
- pro-Gabapentin
- 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.
- Recalling Firm
- Prodoc Limited 2925 Industrial Blvd, Laval, Quebec H7L 3W9
- Recall Posting Date
- 2009-04-27
- Recall Start Date
- 2009-04-09
- Trade Name
- Clindamycine-300
- 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.
- Recalling Firm
- Prodoc Limited 2925 Industrial Blvd, Laval, Quebec H7L 3W9
- Recall Posting Date
- 2009-04-27
- Recall Start Date
- 2009-04-09
- Trade Name
- Clindamycine-150
- 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.
- Recalling Firm
- ratiopharm
17800 Lapointe
Mirabel, Quebec
J7J 1P3 - Recall Posting Date
- 2009-05-25
- Recall Start Date
- 2009-04-30
- Trade Name
- ratio-Bisacodyl
- 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.
- Recalling Firm
- Sepracor Pharmaceuticals, Inc.
6790 Century Avenue, Suite 100,
Mississauga, Ontario
L5N 2V8 - Recall Posting Date
- 2009-05-25
- Recall Start Date
- 2009-05-01
- Trade Name
- Niaspan
- 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.
- Recalling Firm
- Seroyal
490 Elgin Mills Road East
Richmond Hill, Ontario
L4C 0L8 - Recall Posting Date
- 2009-06-22
- Recall Start Date
- 2009-05-19
- Trade Name
- Maxum Multi Vite
Maxum Matragen - 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.
- Recalling Firm
- Steris Canada
6280 Northwest Drive,
Mississauga, Ontario
L4V 1J7 - Recall Posting Date
- 2009-05-25
- Recall Start Date
- 2009-05-13
- Trade Name
- Vaprox Hydrogen Peroxide Sterilant
- 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.
- Recalling Firm
- Tanta Pharmaceuticals Inc., 1009 Burns Street East, Whitby, Ontario
- Recall Posting Date
- 2009-05-11
- Recall Start Date
- 2009-04-09
- Trade Name
- Senna Tablets 30s and 100s / Life Brand, Tanta, Preferred, Encounter
- 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.
- Recalling Firm
- Tanta Pharmaceuticals Inc., 1009 Burns Street East, Whitby, Ontario
- Recall Posting Date
- 2009-05-11
- Recall Start Date
- 2009-04-09
- Trade Name
- Laxative Pills Regular Strength (RS) 12s and 30s / Preferred, Texall, Tanta, Personnelle
- 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.
- Recalling Firm
- Tanta Pharmaceuticals Inc., 1009 Burns Street East, Whitby, Ontario
- Recall Posting Date
- 2009-05-11
- Recall Start Date
- 2009-04-09
- Trade Name
- Laxative Pills ES / Truly, Life Brand, Rexall, Preferred, Rexall, Encounter, Personnelle
- 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.
- Recalling Firm
- Tanta Pharmaceuticals Inc., 1009 Burns Street East, Whitby, Ontario
- Recall Posting Date
- 2009-05-11
- Recall Start Date
- 2009-04-09
- Trade Name
- Senna S Tablets 60s and 10s / Preferred, Life Brand, Encounter, Safeway
- 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.
- Recalling Firm
- Valeant Canada Limited
4787 Levy Street
Montreal, Quebec
H4R 2P9 - Recall Posting Date
- 2009-05-25
- Recall Start Date
- 2009-05-08
- Trade Name
- Rofact
- 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.
- Recalling Firm
- Vita Health Products Inc. 150 Beghin Avenue Winnipeg, Manitoba R2J 3W2
- Recall Posting Date
- 2009-04-27
- Recall Start Date
- 2009-04-13
- Trade Name
- PHSV Senna Lax 8.6MG NAT 100TB
- 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.
- Recalling Firm
- Vita Health Products Inc. 150 Beghin Avenue Winnipeg, Manitoba R2J 3W2
- Recall Posting Date
- 2009-04-27
- Recall Start Date
- 2009-04-13
- 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
- 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.
- Recalling Firm
- Vita Health Products Inc. 150 Beghin Avenue Winnipeg, Manitoba R2J 3W2
- Recall Posting Date
- 2009-04-27
- Recall Start Date
- 2009-04-13
- 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
- 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.
- Recalling Firm
- Wyeth Canada
1025 Marcel-Laurin Boulevard
St-Laurent, Quebec
H4R 1J6 - Recall Posting Date
- 2009-06-22
- Recall Start Date
- 2009-05-25
- Trade Name
- Min-Ovral 21
- 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.
- Recalling Firm
- Wyeth Canada
1025 Marcel-Laurin Boulevard
St-Laurent, Quebec
H4R 1J6 - Recall Posting Date
- 2009-05-25
- Recall Start Date
- 2009-04-30
- Trade Name
- Min-Ovral 28
- 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.
