Yonkers-based Homeocare Laboratories Inc. has enacted a voluntary recall for several of its products following concerns raised by the U.S. Food and Drug Administration (FDA) that its production process fell short of current good manufacturing practices.
“Your firm”™s poor manufacturing practices are particularly concerning because the labeling for several of your products state that they contain potentially toxic ingredients, such as ”˜Aconitum Napellus,”™ ”˜Arsenicum album,”™ and ”˜Belladona,”™ thereby presenting additional risk of serious harm to patients,” said Diana Amador-Toro, FDA program division director and district director, in a letter to the company”™s leadership.
“In addition,” she added, “your poor manufacturing practices are also concerning because some of your products are marketed for use in children, who may be at greater risk for adverse reactions associated with certain drug products due to differences in their ability to absorb, metabolize, distribute, or excrete such drug products or their metabolites.”
The impacted products include Homeocare”™s Kanjo Arnica Cream, DoloEar, SnoreStop Naso Spray and the StellaLife line of dental rinses, sprays and gels.
