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Wholistic Herbs, Inc. "Koff and Kold" and "Kold Sore" Spray: Recall - Non-Sterile Products
AUDIENCE: Consumer
ISSUE: Wholistic Herbs Inc. notified the public it is recalling all quantities of "Koff & Kold" spray with herbal extract and "Kold Sore" spray with liquid sea mineral. "Koff & Kold" spray with herbal extract is intended to be sprayed into the nose and throat for treatment of colds, flu, cough, stuffy nose, and sinus infection. "Kold Sore" spray with liquid sea mineral is intended to be sprayed into the eyes for the treatment of dry eye and pink eye. The product is also intended to be sprayed into the nose for sinus allergy by pollen, and onto the lips and genitals for the treatment of fever blisters, shingles and herpes simplex.
These products are not tested properly to assure their safety. Products intended for use in the eye that are non-sterile have the potential to cause eye infections, which may be sight threatening. Also, nasal solutions that are not sterile could lead to a respiratory infection.
The recall was the result of a routine FDA inspection which identified several labeling issues.
BACKGROUND: "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 at www.naturalapothecary.com. These two spray products were distributed from March 2009 through February 2012.
RECOMMENDATION: Consumers who have purchased "Koff & Kold" and "Kold Sore" are urged to discontinue use of the product and return the product to the place of purchase for a full refund. Consumers with questions may contact the company Monday through Friday 9:00am to 5:00pm CST at 214-691-3210.
Read the MedWatch safety alert, including a link to the firms Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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