Natural health products (Kamizym-U and Kamizym+) recalled due to potential contamination with the antibiotic chloramphenicol

Starting date:
October 17, 2013
Posting date:
October 17, 2013
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Contamination
Audience:
General Public
Identification number:
RA-36315

Issue

Gourmet Nutrition F. B. Inc., in consultation with Health Canada, is voluntarily recalling its natural health products “Kamizym-U" and "Kamizym+” – a digestive aid – due to a possible contamination with chloramphenicol, an antibiotic that may pose serious health risks to consumers. 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 it 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.

Products affected

  1. Kamizym-U (NPN 80036136) Lots: 131151KMU and 131261KMU
  2. Kamizym+ (NPN 80033802) Lot: 131301KPL

What you should do

  • Consult your healthcare practitioner immediately if you have used this product.
  • Report any adverse events using this product to Health Canada.
  • Contact Gourmet Nutrition 1-800-363-7574 and/or 1-450-922-2885 to return the product.

Who is affected

Canadians who have used these products.

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.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada is monitoring the recall of “Kamizym-U” and “Kamizym+” by Gourmet Nutrition.

According to the company, testing of one of the raw materials used to produce this product identified the presence of chloramphenicol.