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Important Recall Information: A number of natural health products potentially contaminated with chloramphenicol may pose serious health risks to consumers
- Starting date:
- October 18, 2013
- Posting date:
- October 18, 2013
- Type of communication:
- Information Update
- Subcategory:
- Natural health products
- Source of recall:
- Health Canada
- Issue:
- Contamination
- Audience:
- General Public
- Identification number:
- RA-36355
Issue
Health Canada wishes to inform Canadians that additional natural health products (see chart below) are being voluntarily recalled by a number of Canadian companies due to a possible contamination with chloramphenicol, an antibiotic that may pose serious health risks to consumers.
Specialty Enzymes & Biotechnologies has provided contaminated raw materials to a number of companies producing natural health products for the Canadian market. As a result, natural health products from these companies are at risk of contamination with chloramphenicol.
The only products Health Canada is currently aware of potentially being contaminated are products used as digestive and menopausal aids. Health Canada is working with Specialty Enzymes & Biotechnologies and its Canadians customers to confirm affected products and will continue to provide updates to Canadians as warranted.
Chloramphenicol is associated with a rare risk of aplastic anemia, a serious blood disorder that can be fatal. This reaction is unpredictable and not related to a specific dose of chloramphenicol.
Chloramphenicol is a prescription drug and should only be used under medical supervision in adults and children after careful consideration of the risks associated with its use. Other side effects that can be associated with chloramphenicol include allergic reactions in people who have sensitivity to the medication, and effects on the bone marrow leading to decreased blood cells. In addition, it should not be used by pregnant or lactating women.
Canadians can monitor the table below for additions to the list of products potentially contaminated with chloramphenicol that may pose a serious risk to their health.
| Company | Product name | NPN | Lot(s) | Usage | Date Added |
|---|---|---|---|---|---|
| Kirkman | Phenol Assist™ | Unauthorized |
|
Digestive Aid | December 23, 2013 |
| Kirkman | Biofilm Defense® | Unauthorized |
|
December 23, 2013 | |
| Kirkman | Enzym-Complete/DPP-IV™ | Unauthorized |
|
Digestive Aid | December 23, 2013 |
| Kirkman | EnZym-Complete/DPP-IV™ II with Isogest® | Unauthorized |
|
Digestive Aid | December 23, 2013 |
| Kirkman | Maximum Spectrum Enzym-Complete/DPP-IV™ Fruit Free with Isogest® | Unauthorized |
|
Digestive Aid | December 23, 2013 |
| Kirkman | Chewable EnZym-Complete/DPP-IV™ with Isogest® | Unauthorized |
|
Digestive Aid | December 23, 2013 |
| Kirkman | Chewable Maximum Spectrum EnZym-Complete/DPP-IV™ with Isogest® | Unauthorized |
|
Digestive Aid | December 23, 2013 |
| General Nutrition Centres Company (GNC) | Women’s Phytoestrogen Formula | 80036006 |
|
Relief of menopausal symptoms | December 17, 2013 |
| Tall Grass Distribution | Mega Foods High Active Enzymes | N/A |
|
Digestive aid | November 21, 2013 |
| Tall Grass Distribution | Mega Foods Gluten & Dairy MegaZymes (30 tablets) | N/A |
|
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November 21, 2013 |
| Tall Grass Distribution | Mega Foods Gluten & Dairy MegaZymes (60 tablets) | N/A |
|
Digestive aid | November 21, 2013 |
| Tall Grass Distribution | Mega Foods Vegan-Ease Digestive Enzymes | 80035934 |
|
Digestive aid | November 21, 2013 |
| Sequel Naturals Ltd. | Various products | Various NHPs | Various lots | Digestive aid | November 6, 2013 |
| Valeant Canada Consumer Products | Digestive Enzymes 500mg Capsules | 80033138 |
|
Digestive aid | October 21, 2013 |
| Natural Factors Nutritional Products Limited | Multi Enzyme capsules | 02245142 |
|
Digestive aid | October 19, 2013 |
| Natural Factors Nutritional Products Limited | Complete Megazymes tablets | 00506508 |
|
Digestive aid | October 19, 2013 |
| WN Pharmaceuticals® Ltd | Complete digestive Enzymes capsules | 02248630 |
|
Digestive aid | October 19, 2013 |
| WN Pharmaceuticals® Ltd | Complete digestive Enzymes capsules - blister pack | 02248630 |
|
Digestive aid | October 19, 2013 |
| WN Pharmaceuticals® Ltd | Digestive Enzymes tablets | 02240677 |
|
Digestive aid | October 19, 2013 |
| Renew Life Canada Inc. | GasStop | 80036717 |
|
Digestive aid | October 19, 2013 |
| Renew Life Canada Inc. |
DigestMORE HCl; Advanced Naturals DigestMAX HCl |
80037271 |
|
Digestive aid | October 19, 2013 |
| Renew Life Canada Inc. |
DigestMORE; Advanced Naturals DigestMAX |
80005847 |
|
Digestive aid | October 19, 2013 |
| Renew Life Canada Inc. | CandiZYME | 80036437 |
|
Digestive aid | October 19, 2013 |
| Renew Life Canada Inc. | DigestMORE ULTRA | 80037290 |
|
Digestive aid | October 19, 2013 |
|
Future Formulations Inc. 1-800-465-2873 x223 |
NaturPham M2+ | 02240497 |
|
Digestive aid | October 18, 2013 |
|
Future Formulations Inc. 1-800-465-2873 x223 |
NaturPham M3+ | 02240501 |
|
Digestive aid | October 18, 2013 |
|
Future Formulations Inc. 1-800-465-2873 x223 |
NaturPham M4+ | 02240561 |
|
Digestive aid | October 18, 2013 |
|
Future Formulations Inc. 1-800-465-2873 x223 |
NaturPham M5+ | 02240572 |
|
Digestive aid | October 18, 2013 |
|
Future Formulations Inc. 1-800-465-2873 x223 |
NaturPham M6 | 02239966 |
|
Digestive aid | October 18, 2013 |
|
Future Formulations Inc. 1-800-465-2873 x223 |
NaturPham M7+ Capsules | 02240571 |
|
Digestive aid | October 18, 2013 |
| Future Formulations Inc. | Future Formulations Digestion Formula Forte | 02240559 |
|
Digestive aid | October 18, 2013 |
|
Future Formulations Inc. 1-800-465-2873 x223 |
Future Formulations Digestion Formula C | 02240495 |
|
Digestive aid | October 18, 2013 |
|
Future Formulations Inc. 1-800-465-2873 x223 |
Future Formulations Digestion Formula F | 02240496 |
|
Digestive aid | October 18, 2013 |
|
Future Formulations Inc. 1-800-465-2873 x223 |
Future Formulations Tumi-Ease | 02239965 |
|
Digestive aid | October 18, 2013 |
|
Accurex Health Care Manufacturing Inc. 519-752-4937 |
Health First - PrimeZyme Plus Betaine | 80039724 |
|
Digestive aid | October 18, 2013 |
|
Gourmet Nutrition 1-800-363-7574 |
Kamizym-U | 80036136 |
|
Digestive aid | October 17, 2013 |
|
Gourmet Nutrition 1-800-363-7574 |
Kamizym+ | 80033802 |
|
Digestive aid | October 17, 2013 |
|
Metagenics Canada 1-800-268-6200 |
Spectrazyme | 80044751 |
|
Digestive aid | October 11, 2013 |
|
Adeeva Nutritionals 1-888-251-1010 (ext. 1014) |
Flora Essentials | 80039819 |
|
Digestive aid | October 10, 2013 |
Report health or safety concerns
- Call toll-free at 1-866-234-2345
- Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
Related AWRs
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