Unauthorized "Smart Brain Formulations Serotonin Support" may pose serious health risks

Starting date:
December 1, 2017
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Unauthorized products
Audience:
General Public
Identification number:
RA-65304

Issue

Health Canada is advising Canadians that the unauthorized health product “Smart Brain Formulations Serotonin Support” may pose serious health risks. The product is labelled to contain lithium orotate, which is a prescription drug and should be used only under the supervision of a health care professional. Health Canada testing also found bacterial contamination with E. coli, which can cause serious health problems. The product was being offered for sale by the company Robert Lamberton Consulting, by email. The company currently does not hold a site licence or any product licences with Health Canada.

Products affected

Smart Brain Formulations Serotonin Support

What you should do

  • If you are using this product, consult with your health care professional to receive advice on safely stopping use and appropriate treatment for your medical condition.
  • Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have been authorized for sale by searching Health Canada’s Drug Product Database and Licensed Natural Health Product Database.
  • 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.

Who is affected

Consumers who have bought or used Smart Brain Formulations Serotonin Support

Background

Lithium is a prescription drug and is approved for treatment of manic episodes of manic-depressive illness. Common lithium side effects include increased thirst and urination, hand tremors and drowsiness. Severe dehydration has been reported. Intoxication can occur, especially when taken with other medications. Symptoms of intoxication can include vomiting, diarrhea, muscle twitches and lethargy. Patients should take lithium only after receiving a diagnosis and prescription from a health care professional. Otherwise, patients risk inappropriate treatment for their condition and harmful drug interactions or side effects.

E. coli are bacteria that live naturally in the intestines of some animals, and can be found in their feces. People infected with E. coli can have a wide range of symptoms. Common symptoms of E. coli can appear within one to ten days after contact with the bacteria, and include severe stomach cramps, profuse watery or bloody diarrhea, vomiting, nausea and headache. Young children aged 5 and under, older adults, and people with weakened immune systems are more likely to get sick and their symptoms may be more severe.

Media enquiries

Health Canada
613-957-2983

Public enquiries

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

What Health Canada is doing

Health Canada is following up and will take further compliance and enforcement action as necessary. If additional retailers or distributors of these products are identified, Health Canada will take appropriate action and inform Canadians.

Images

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For more information

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools. To learn more about natural health products and other self-care products, visit Canada.ca/selfcare-products.
 
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