Advisory - Flintstones Plus Iron multivitamins for children: One bottle found to contain unidentified capsules instead of chewable tablets

OTTAWA, Jan. 12, 2018 /CNW/ - 

Issue
Health Canada is advising Canadians that one bottle of children's "Flintstones Plus Iron" multivitamins (NPN 02247995) was returned to a pharmacy containing unidentified capsules instead of the proper chewable tablets, which are multi-coloured tablets shaped like Flintstones characters. The opened bottle with the safety seal removed was returned to a Pharmaprix in Longueuil, QC, in December 2017.

At this time, Health Canada and the company, Bayer Inc., are aware of only one incident involving this product.

Who is affected

• Consumers who have bought or used Flintstones Plus Iron multivitamins

Affected products

• Flintstones Plus Iron multivitamins (NPN 02247995)

What consumers should do

• Inspect the bottle to be sure the bottle contains the proper chewable tablets before giving to a child. In general, check any health product before consuming it to make sure it appears as expected. If in doubt, check with a pharmacist.
• Check product packaging before buying to make sure they have not been opened, torn, damaged or otherwise tampered with.
• Consult with your health care professional if your child has consumed unidentified capsules and has health concerns.
• Contact Bayer Inc. with any concerns about this product by calling toll-free at 1-800-714-4449.
• Report adverse events to health products to Health Canada by calling toll-free at 1?866?234?2345, or by reporting online, by mail or by fax.
• Report complaints about health products to Health Canada by calling toll-free at 1?800?267?9675, or complete an online complaint form.

Background
Health Canada was notified of the issue by the pharmacy. Bayer has informed Health Canada that it has completed an investigation and has concluded that the unidentified capsules found in the bottle were not due to an issue at the Bayer manufacturing site. The investigation also concluded that the unidentified capsules are not a product manufactured or sold by Bayer.

The health risks of consuming the unidentified capsules are not known.

What Health Canada is doing
Health Canada is testing the unidentified capsules. Should Health Canada become aware of additional safety information, it will take appropriate action and inform Canadians as necessary.

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SOURCE Health Canada