Health Canada

Health Canada

February 17, 2009 13:38 ET

Health Canada Informs Women Taking the Prescribed Supplement "PregVit Folic 5" and "PregVit" to Check Product Packaging

OTTAWA, ONTARIO--(Marketwire - Feb. 17, 2009) - Health Canada is informing expectant mothers and women who are planning pregnancy taking the product PregVit Folic 5 and/or PregVit distributed by Duchesnay Inc. to check the product's individual sealed packages. Reports related to incorrect packaging of some blister packs have been received by Health Canada; however no concerns have been raised regarding the tablets themselves.

Individual sealed packages of PregVit Folic 5 and PregVit should contain a pink blister pack of pink tablets to be taken in the morning, and a blue blister pack of blue tablets, to be taken in the evening. The pink and the blue tablets do not contain the same active ingredients and their daily intake is complementary. Health Canada was informed that some of the individual sealed packages, which should contain both a pink and a blue blister pack, contained only pink or only blue blister packs. Consumers are advised to check the individual, sealed packages to ensure they contain both a pink and a blue blister pack so that they receive the optimal amount of vitamin and mineral supplements. Women taking Preg Vit Folic 5 and PregVit should continue taking the prescribed amount of pink and blue tablets per day as directed by their health care professional.

The following lot numbers have been identified as potentially having some incorrectly packaged product: PregVit Folic 5 Lot 7003 (expiry date May 2009) and Lot 8008 (expiry date November 2009) and PregVit Lot 7021 (expiry date May 2009) and 7027 (expiry date May 2009). Health Canada has been in contact with the distributor Duchesnay Inc.

Consumers with the incorrectly packaged products are advised to consult their pharmacist to get a new package. Consumers with the correctly packaged products should continue taking the prescribed product as directed by their health care professional.

Health Canada has not received any adverse reaction reports related to the mis-packaging of these products in Canada. Preventive benefits, as well as vitamin and mineral supplementation will be optimized by using correctly packaged products.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

- Report online (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) at the MedEffect™ Canada Web site

- Call toll-free at 1-866-234-2345

- Complete a Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php)and either:



- Fax toll-free to 1-866-678-6789
- Mail to: Canada Vigilance Program
Health Canada
AL 0701C
Ottawa, ON K1A 0K9


To have postage pre-paid, download the postage paid label (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/post_paid-affranchi-eng.php) from the MedEffect™ Canada Web site. The Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and the adverse reaction reporting guidelines may also be obtained via this Web site.

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Contact Information

  • Media Inquiries:
    Health Canada
    613-957-2983
    or
    Public Inquiries:
    613-957-2991
    1-866-225-0709