“Kold Sore”, “Koff and Kold” by Wholistic Herbs Inc. Recall: Non-Sterile

Consumers and the public are being alerted of the recall for Wholistic Herbs Inc. products: “Kold Sore” plus “Koff and Kold”. This recall was instigated following a routine checkup by the FDA whose analysis established various issues with the product label.

Background of “Kold Sore” and “Koff and Kold”

The recalled products from Wholistic Herbs Inc. are in the form of sprays, whereby Kold Sore has liquid-form sea minerals while Koff and Kold has herbal extracts.

Below is an outline of what these Wholistic Herbs medical sprays are indicated for:

Kold Sore:

• Liquid spray that has sea minerals
• Usage: sprayed directly into the eyes, nose, lips, genitals
• Treatment: pink eye, dry eyes, sinus allergy, blisters (from fever), herpes simplex, shingles

Koff and Kold:

• Liquid spray that has herbal extracts
• Usage: sprayed directly into the throat, noose
• Treatment: flu, cough, colds, sinus infections, blocked nose

The distribution network for both the products Kold Sore and Koff and Kold covered the entire US with acupuncture shops and retail stores in Virginia, New York, Georgia, Texas, South Carolina, North Carolina, Maryland, Florida, Nevada, Washington, Illinois, New Jersey, Arizona and California.

The manufacturer’s website, naturalapothecary.com was also distributing the spray products whose distribution has spanned from Mar 2009 to Feb 2012.

FDA Alert

Pursuant to the recall, the FDA has alerted consumers of the risk associated with the aforementioned products (“Kold Sore” and “Koff and Kold”) from Wholistic Herbs Inc. with the products not having tested appropriately for safety assurance.

Non-sterile products that are directly administered to the eye could lead to infections of the eye and potential harm to the person’s eyesight.

The same goes for non-sterile products that are directly administered to the nose, as these could lead to infections of the respiratory tract.

FDA 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. ”

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