U.S. Food and Drug Administration

 FDA News Release,  July 31, 2001

Pacific Biologic Recalls Seven Herbal Products That Contain the Herb Akebia Trifoliata Caulis (Mu Tong) and the Herb Asarum Sieboldii Herba Cum Radix (Xi Xin) Because of a Possible Health Risk

For Immediate Release

Clayton, CA - July 31, 2001 -- Pacific BioLogic Co. is recalling capsules containing the herb Akebia Trifoliata Caulis (Mu Tong) and the herb Asarum Sieboldii Herba cum Radix (Xi Xin); as these herbs may present a serious health hazard to consumers. These herbs contain aristolochic acid. Aristolochic acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. This chemical can cause serious kidney damage and the use of products that contain aristolochic acid has been associated with several occurrences of kidney failure. The use of aristolochic acid containing products has been linked to increased risk of kidney cancer in people who have consumed it.

The herb Akebia Trifoliata Caulis (Mu Tong) and the herb Asarum Sieboldii Herba cum Radix (Xi Xin) were part of the formula for products listed below and distributed nationwide to medical doctors, naturopathic physicians, licensed acupuncturists, and herbal practitioners. The products were labeled under the following brands and includes all lots and production codes:

HERBAL MASTERS ARPANEX B
HERBAL MASTERS CYS
HERBAL MASTERS KOMS A
BALANCE & HARMONY ARTIFLEX B
BALANCE & HARMONY GENTIANA COMBINATION
BALANCE & HARMONY ALLERHAY
PACIFIC BIOLOGIC ORTHOFLEX

These herbs were sold in white plastic bottles containing capsules of herb powder with labels identifying the herb as Akebia Trifoliata Caulis (Mu Tong) and the herb Asarum Sieboldii Herba cum Radix (Xi Xin).

No illness has been reported to date.

The recall was the result of a notice from the US Food and Drug Administration that aristolochic acid has been classified as a Class 1 toxic substance. The company has ceased the production and distribution of all forms of these herbs.

Consumers who have purchased or been prescribed these herbs should immediately discontinue their use and return them to the place of purchase for a full refund. Consumers with questions may contact the company at (925) 673-2967.

The FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties. The FDA does not endorse either the product or the company.

The text in this article was prepared by the FDA Office of Public Affairs.