WASHINGTON -- The manufacturer of Revital, a wound-healer made from chicken feet, is recalling its powder and gel products because of potentially dangerous contamination, the Food and Drug Administration said Wednesday.
The manufacturer, Robertson Resources Ltd., of Salisbury, Md., wrote 3,000 distributors this month telling them not to sell 12-gram plastic containers of powder, and 55-gram containers of gel, FDA officials said.
The recall is a Class I action, the most serious possible, because of a 'reasonable possibility' the product could cause harmful health consequences or death, FDA said.
FDA officials said they had heard no reports of serious harm from use of the product, which is contaminated with bacteria.
Revital also comes in tablet form, which the FDA says is an unapproved new drug and subject to seizure. But contamination of the tablets was not serious enough to warrant a recall, officials said.
U.S. marshals seized $155,000 worth of Revital powder and gel from a Maryland warehouse Oct. 20. Eight days later, FDA officials asked the company to recall the product, distributed by mail order and through some pharmacies, health food stores, hospitals, clinics and doctors' offices.
The product, made from chicken feet, is sold as a wound-healer. FDA officials say people who use it might not realize Revital had harmed them until a serious infection resulted.
Health officials in Kansas banned the product last month.
Revital powder and gel also were recalled in April for similar bacterial contamination, FDA said.