Koff & Kold and Kold Sore

Starting date:

June 4, 2012

Posting date:

June 4, 2012

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Product Safety, Labelling and Packaging

Audience:

General Public

Identification number:

RA-15027

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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

• Koff & Kold
• Kold Sore

Manufacturer / Place of origin

Wholistic Herbs Inc., of Dallas, Texas, U.S.

Product description

Koff & Kold is promoted as an "all-natural" nose and throat spray used for the relief colds, flu, cough, stuffy nose, and sinus infection.

Kold Sore is promoted as an "all-natural" eye spray used for the treatment of dry eye and pink eye. It is also promoted as a nose spray used for the relief of sinus allergies, and as a spray for the lips and genitals for the treatment of fever blisters, shingles and herpes simplex.

Reason for warning

The U.S. Food and Drug Administration (FDA) informed consumers of a company recall in the U.S. after Koff & Kold and Kold Sore bottles were found to be non-sterile.

A routine U.S. FDA inspection identified several labeling issues, and that these products are not tested properly as to assure their safety.

According to the company press release, Koff & Kold and Kold Sore were distributed throughout the Unites States to retail stores located in Texas, California, Washington, Virginia, New Jersey, New York, Maryland, Illinois, Georgia, Nevada, Arizona, North Carolina, South Carolina, and Florida. The products were also distributed through acupuncture clinics and the firm's website. Consumers with questions may contact the Wholistic Herbs Inc. directly, Monday through Friday 9:00 a.m. to 5:00 p.m. CDST at 214-691-3210 for instructions on the return process.

Possible side effects

Products intended for use in the eye that are non-sterile have the potential to cause sight-threatening eye infections. Nasal solutions that are non-sterile could lead to respiratory infections.

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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