The U.S. Drug and Food Administration announced a recall of Koff & Kold spray with herbal extract, manufactured by Texas-based Wholistic Herbs Inc.
The product is intended to be sprayed into the nose and throat for treatment of colds, flu, cough, stuffy nose and sinus infection.
The recall was the result of a routine FDA inspection which identified several labeling problems.
The company's 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, according to the FDA press release.
Both products were found to be not sterile and have the potential to cause infections, officials said.
The medications were distributed to retail stores in several states, including Washington, and distributed through acupuncture clinics and the firm's website at www.naturalapothecary.com from March 2009 through February.
Koff & Kold and Kold Sore are packaged in white, plastic, one-ounce spray bottles with clear plastic lids.
The products are identified with a "USE BY" date on the bottom of the bottle, all if which are being recalled.
No illnesses have been reported to date.
People who have purchased the medications are urged to discontinue use of the product and return the product to the place of purchase for a full refund. For more information call 214-691-3210.