Wholistic Herbs Recall Non-sterile

February 27, 2012 by staff 

Wholistic Herbs Recall Non-sterile, Wholistic Herbs Inc. of Dallas, TX, is recalling all quantities of its 1-fluid-ounce Koff and Kold and Kold Sore spray products distributed from March 2009 through February 2012. 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 that identified several labeling issues. These products are not tested properly as to assure their safety.

Wholistic Herbs, Inc. Koff & Kold spray with herbal extract as the product is not sterile and is intended to be sprayed into the nose and throat for treatment of colds, flu, cough, stuffy nose, and sinus infection.

Wholistic Herbs, Inc. Kold Sore spray with liquid sea mineral as the product is not sterile and 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.

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

Koff & Kold and Kold Sore are packaged in white plastic 1-fluid-ounce spray bottles that contain a product insert inside of the clear plastic lid. The product insert provides usage instructions to customers. The products are identified with a “use by” date on the bottom of the bottle. All used by dates are being recalled.

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