Herbal Nasal Sprays Found to Be Unsterile Recalled

On behalf of Brown & Crouppen, P.C. posted in Defective Products on Thursday, February 16, 2012

A company that manufactures nasal and eye sprays for treatment of sinus infections and dry eye is recalling two of its products after the Food and Drug Administration found that non-sterile packaging could expose users to infections and potential blindness. The nasal sprays, called “Koff & Kold” and “Kold Sore,” were not distributed to retail stores in Missouri, but they were available online and in Illinois, potentially putting St. Louis-area consumers within range of the recall.

The sprays are manufactured by a company named Wholistic Herbs Inc. According to the Missouri Department of Health and Senior Services, the Koff & Kold spray is a nasal and throat spray treated with herbal extract and intended to treat the symptoms of a variety of illnesses such as colds, the flu and sinus infections. Kold Sore includes liquid sea mineral in its ingredients and is supposed to be sprayed into users’ eyes to treat dry eye and pink eye, or into the nose to counteract pollen allergies. The product is also advertised as a treatment for herpes blisters and shingles.

FDA officials found the products were not sterile and could cause infections if used. An eye infection from using Kold Sore could be especially serious and lead to loss of vision, the agency said in a press release.

The spray bottles contained one fluid ounce of product and were distributed from March 2009 through February 2012. Consumers who have one of the recalled bottles are urged to stop using them immediately and bring them back to the store for a full refund.

Source: Walla Walla Union-Bulletin, “Koff & Kold, Kold Sore recalled,” Feb. 10, 2012

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