Foreign Product Alert: Dr. Larry's Tranquility

Starting date:

April 24, 2014

Posting date:

April 24, 2014

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Drugs, Natural health products

Source of recall:

Health Canada

Source of alert:

U.S. Food and Drug Administration

Issue:

Undeclared Substance

Audience:

General Public

Identification number:

RA-38823

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Introduction

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

Affected product

• Dr. Larry's Tranquility

Dr. Larry's Tranquility

Product description

This product is promoted as a sleep aid.

The recalled products are packaged in a white bottle with 30 pills per bottle bearing the lot numbers 36678 and 36680 and the expiration date of 9/15.

Hazard identified

The U.S. Food and Drug Administration warned consumers not to use this product after it was found to contain undeclared doxepin and chlorpromazine, drug ingredients that were not declared on the product label.

Doxepin is a prescription drug used to treat depression, anxiety and sleep disorders. Doxepin should only be taken under the supervision of a healthcare professional.

Chlorpromazine is a prescription used to treat mental illness such as schizophrenia. It can also be used to treat nausea and vomiting. Chlorpromazine should only be taken under the supervision of a healthcare professional.

Place of origin

Health and Beyond LLC, located in Boca Raton, FL, U.S.A.

Side effects

Side effects associated with doxepin include drowsiness, constipation, dry mouth and headache.

Side effects associated with chlorpromazine include drowsiness or agitation, difficulty urinating, sexual dysfunction and involuntary body movements. Other side effects such as muscle stiffness, fever and confusion, and can be life threatening when they are not recognized and addressed early.

What you should do

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.

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

Background

Drugs and natural health products that are authorized for sale in Canada will have 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 April 4, 2014, no adverse reactions suspected to be associated with the use of this product had been reported to Health Canada.

Report a health or safety concern

To report a side effect to a health product to Health Canada:

• 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

Images

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