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“Koff & Kold” and “Kold Sore” Recalled

Ramona Roberts5 years ago

The Food and Drug Administration (FDA) issued a recall on all quantities of “Koff & Kold” and “Kold Sore” products sold by Wholistic Herbs Inc. of Dallas, Texas due to labeling problems and health risks.

About the “Koff & Kold” and “Kold Sore” Recall

Wholestic Herbs recalled all quantities of “Koff & Kold” and “Kold Sore” distributed from March 2009 through February 2012 after they were found to be un-sterile and had the potential to cause infections. The recall was the result of a routine FDA inspection, which found the products to be improperly labeled and untested.

“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,” FDA.

“Koff & Kold” Product Information

  • Wholistic Herbs, Inc. “Koff & Kold” is a 1 fl. oz. spray with herbal extract used for treatment of coughs and stuffy nose during colds and flu.
  • The spray comes in a white plastic bottle with a product insert inside the clear lid explaining the product's usage instructions.
  • The spray was distributed in the following states: Texas, California, Washington, Virginia, New Jersey, New York, Maryland, Illinois, Georgia, Nevada, Arizona, North Carolina, South Carolina, and Florida. The spray was also distributed through acupuncture clinics and on the firm's website www.naturalapothecary.com.
  • All used-by dates are being recalled.
“Kold Sore” Product Information
  • Wholistic Herbs, Inc. “Kold Sore” is a 1 fl. oz. spray with liquid sea mineral used for treatment of pink eye, dry eye, fever blisters, shingles, and herpes simplex.
  • The spray is to be used on the lips, genitals, and in the eye and nose.
  • The spray comes in a white plastic bottle with a product insert inside the lid, explaining the product's usage instructions.
  • The spray was distributed in the following states: Texas, California, Washington, Virginia, New Jersey, New York, Maryland, Illinois, Georgia, Nevada, Arizona, North Carolina, South Carolina, and Florida. The spray was also distributed through acupuncture clinics and on the firm's website.
  • All used by dates are being recalled.
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