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Foreign product alert

iFlora Kids Multi-Probiotic - florAlign PREBIOTIC FORMULA - Wellesse Digestive 3-in-1 Health

Starting date:
December 21, 2012
Posting date:
December 21, 2012
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Contamination, Important Safety Information
Audience:
General Public
Identification number:
RA-16377

These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Source of alert

U.S. Food and Drug Administration

Product names

  • iFlora Kids Multi-Probiotic
  • florAlign PREBIOTIC FORMULA
  • Wellesse Digestive 3-in-1 Health

Manufacturer / Place of origin

  • iFlora Kids Multi-Probiotic is manufactured by Sedona Labs
  • florAlign PREBIOTIC FORMULA is manufactured by Northridge Labs and distributed by Eco Health, Inc.
  • Wellesse Digestive 3-in-1 Health is manufactured by Botancal Laboratories

Product description

These products are promoted as digestive aids.

Reason for warning

The U.S. Food and Drug Administration informed consumers of separate and unrelated voluntary company recalls of certain lots of these three products due to possible Salmonella contamination.

Salmonella are bacteria that cause intestinal illness (salmonellosis) in humans, usually from the consumption of contaminated food or health products. The risk of serious health effects is greatest for young children, seniors and people with weak immune systems.

The affected lots of each product are as follows:

iFlora Kids Multi-Probiotic: The recalled lots were distributed between March 16, 2011, and May 3, 2012. Consumers wishing for more information on the recall may contact the company directly at 1-888-816-8804.

iFlora Kids Multi-Probiotic
Lot Number UPC Code
1074711 6 48575 01013 2
1479611 6 48575 01013 2
1640811 6 48575 01013 2
1734411 6 48575 01013 2
1595811   6 48575 01014 9
2089411 6 48575 01014 9

florAlign PREBIOTIC FORMULA: Three product sizes are affected in this recall.  The affected products were distributed between June 2011 and August 2012:

florAlign PREBIOTIC FORMULA
Product Size UPC Code
90 gram FA02-90GM
180 gram FA02-180GM
270 gram FA02-270GM
Wellesse Digestive 3-in-1 Health
Size Lot #
16 oz LOT 34441C (followed by a four-digit time code) A EXP 03/2014
33.8 oz LOT 34552C (followed by a four-digit time code) A EXP 03/2014

Possible side effects

Side effects associated with the ingestion of Salmonella include severe infection, nausea, vomiting, abdominal pain and diarrhea.

What you should do

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.

Background

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.

Report a health or safety concern

  • Call toll-free at 1-866-234-2345
  • Visit Health 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

Images

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