FDA NewsDepartment of Health and Human Services
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FOR IMMEDIATE RELEASE
P01-14
June 20, 2001
Print Media: 202-205-4144
Consumer Inquiries: 888-INFO-FDA

FDA ISSUES A NATIONWIDE ALERT ON THE RECALL OF THIRTEEN "TREASURE OF THE EAST" HERBAL PRODUCTS BECAUSE OF POSSIBLE HEALTH RISK

The FDA is warning consumers to discontinue use of thirteen Chinese herbal products containing aristolochic acid because they may present a serious health hazard to consumers. Aristolochic acid found in certain plants and botanicals is toxic to the kidneys and is a potent carcinogen. 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 also been linked to increased risk of kidney cancer in people who have consumed it.

Blue Light, Inc., Ithaca, N.Y., has initiated a recall of these products sold under the "Treasure of the East" label with "MFG No. 200008" (2000=year, 08=month) and earlier production dates. Products with "MFG No. 200009" and later production dates are not affected.

Products include:

Item # Single-ingredient
100176-0 Guan) Mu Tong
100644-2 Ma Dou Ling (Mi)

 

Item # Herbal combinations
B015 Ba Zheng San
D060 Dang Gui Si Ni Tang
D075 Dao Chi San
F050 Fu Fang Di Hu Tang
G005 Gan Lu Xiao Du Dan
K030 Kou Yan Ning
L070 Long Dan Xie Gan Tang
P005 Pai Shi Tang
X072 Xiao Ji Yin Zi
X125 Xin Yi San
Y020 Yang Yin Xiao Yan Tang

These products were distributed nationwide in small quantities primarily to acupuncturists, herbalists, and herbal stores. They are in powder form (3.5 oz. bottles) or capsule form (100 per bottle) under the "Treasure of the East" label.

The recall was initiated as a result of public health concerns associated with the consumption of aristolochic acid products. No illnesses have been reported. Blue Light, Inc., has discontinued the distribution and use of products that may contain aristolochic acid.

Consumers who have purchased any of these products with affected expiration dates should discontinue their use and may return them to place of purchase for a full refund. Consumers with questions may contact the company at 1-888-258-3548.


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