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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