August 1, 2001Pacific Biologic Recalls Seven
Herbal Products That Contain the Herb Akebia Trifoliata Caulis (Mu Tong) and the Herb
Asarum Sieboldii Herba Cum Radix (Xi Xin)
CA (SafetyAlerts) - 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
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.
Notice of this product warning was
sent via email to SafetyAlerts
subscribers August 1, 2001. For more information regarding the SafetyAlerts free
email alert service please click here.