Eye and nasal sprays made by Dallas, Texas-based Wholistic Herbs Inc., are being recalled because the solutions may not be sterile and could lead to infections. The recall includes all quantities of Wholistic Herbs “Koff & Kold” spray with herbal extract and “Kold Sore” spray with liquid sea mineral in 1 fl. oz. sprays distributed from March 2009 through February 2012.

“Koff & Kold” is intended to be sprayed into the nose and throat for treatment of colds, flu, cough, stuffy nose, and sinus infection. “Kold Sore” spray is intended to be sprayed into the eyes for the treatment of dry eye and pink eye. It 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.

Non-sterile nasal solutions could lead to a respiratory infection, and eye solutions that are not sterile have the potential to cause eye infections.

The products were distributed throughout the United States to retail stores in Texas, California, Virginia, New Jersey, New York, Maryland, Illinois, Georgia, Nevada, Arizona, North Carolina, South Carolina, and Florida. They were also distributed through acupuncture clinics and at the firm’s website at www.naturalapothecary.com.

No illnesses have been reported to date. The recall was the result of a routine inspection conducted by the Food and Drug Administration (FDA). During the investigation the FDA identified several labeling issues. These products are not tested properly as to assure their safety.

Customers who have these products are urged to stop using them immediately and return them to the place where they purchased them for a full refund. Any side effects associated with these products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA