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October 18, 2001

Blue Light Recalls Treasure of the East brand Chinese herbal products

Ithaca, NY (SafetyAlerts) - The Food and Drug Administration (FDA) said that Blue Light, Inc. is recalling Treasure of the East brand Chinese herbal products, sold in powder form in 3.5 oz. bottle and/or capsules, 100 per bottle.

This is the first public notice of this Class I recall issued by the FDA.

RECALL NUMBER, PRODUCT AND CODE:
Treasure of the East brand Chinese herbal products, sold in powder form in 3.5 oz. bottle and/or capsules, 100 per bottle.

F-006-2, Guan Mu Tong, 3.5 oz bottle (powder) Item # 100176-0. Product was listed in catalog as Mu Tong (Akebia caulis). Product was actually Guan Mu Tong which contains aristolochia. Product labels identified item as Guan Mu Tong. This product was sold as a single ingredient powder and was also used as an ingredient to manufacture 11 combination formulas.

F-007-2, Ma Dou Ling , 3.5 oz bottle (powder), Item #100644-2. This product contains aristolochia spp. and was only sold as a single ingredient product. It was not used to manufacture combination products.

F-008-2, Ba Zheng San , 3.5 oz bottle (powder) & 100 capsule bottle, Item #B015. Recalled product contained 8 ingredients including 13% Guan Mu Tong (aristolochia).

F-009-2, Dang Gui Si Ni Tang, 3.5 oz bottle (powder) & 100 capsule bottle, Item #D060. Recalled product contained 8 ingredients including 12% Guan Mu Tong (aristolochia).

F-010-2, Dao Chi San, 3.5 oz bottle (powder) & 100 capsule bottles, Item #D075. Recalled product contained 4 ingredients including 25% Guan Mu Tong.

F-011-2, Fu Fang Di Hu Tang, 3.5 oz bottle (powder) & 100 capsule bottles, Item #F050. Recalled product contained 9 ingredients including 8% Guan Mu Tong (aristolochia).

F-012-2, Gan Lu Xiao Du Dan, 3.5 oz bottle (powder) & 100 capsule bottles, Item #G005. Recalled product contained 12 ingredients including 7% Guan Mu Tong (aristolochia).

F-013-2, Kou Yan Ning, 3.5 oz bottle (powder) & 100 capsule bottles, Item #K030. Recalled product contained 8 ingredients including 6% Guan Mu Tong (aristolochia).

F-014-2, Long Dan Xie Gan Tang, 3.5 oz bottle (powder) & 100 capsule bottles, Item #L070. Recalled product contained 9 ingredients including 12% Guan Mu Tong (aristolochia).

F-015-2, Pai Shi Tang, 3.5 oz bottle (powder) & 100 capsule bottles, Item #P005. Recalled product contained 9 ingredients including 9% Guan Mu Tong (aristolochia).

F-016-2, Xiao Ji Yin Zi, 3.5 oz bottle (powder) & 100 capsule bottles, Item #X072. Recalled product contained 10 ingredients including 7% Guan Mu Tong (aristolochia).

F-017-2, Xin Yi San, 3.5 oz bottle (powder) & 100 capsule bottles, Item #X125. Recalled product contained 10 ingredients including 10% Guan Mu Tong (aristolochia).

F-018-2, Yang Yin Xiao Yan Tang, 3.5 oz bottle (powder) & 100 capsule bottles, Item #Y020. Recalled product contained 8 ingredients including 21% Guan Mu Tong (aristolochia). Codes: Products with "MFG NO." of 2000 08 (=August 2000) and lower are subject to recall. Both the single ingredient products and the combination products are identified with the year and month of production (i.e. "2001 03") and a use by date which is three years from the date of manufacture (i.e. 03 2004).

NOTE: Products with a lot number of 2000 09 or greater are NOT under recall.

REASON:
Products contain aristolochic acid, a potent carcinogen and nephrotoxin.

MANUFACTURER:
F-006/007-2: Tianjiang Pharmaceutical Co. Ltd., China
F-008/018-2: Blue Light, Inc. Ithaca, NY

RECALLED BY:
Blue Light, Inc., Ithaca, NY by letters issued in March 2001 and June 19, 2001. FDA issued a Press Release on 6/20/01 regarding this recall.

FIRM INITIATED RECALL:
Completed

DISTRIBUTION:
Nationwide

QUANTITY:
Approximate quantities distributed are:
Guan Mu Tong: 193 x 3.5 oz bottles
Ma Dou Ling: 35 x 3.5 oz bottles
Ba Zheng San: 60 x 3.5 oz btls & 51 x 100-capsule bottles
Dang Gui Si Ni Tang: 56 x 3.5 oz btls, 84 x 100-capsule bottles
Dao Chi San: 8 x 3.5 oz bottles & 10 x 100-capsule bottles
Fu Fang Di Hu Tang: 88 x 3.5 oz bottles & 113 x 100-capsulebottles
Gan Lu Xiao Du Dan: 7 x 3.5 oz bottles & 12 x 100-capsulebottles
Kou Yan Ning: 28 x 3.5 oz bottles & 24 x 100- capsule bottles
Long Dan Xie Gan Tang: 159 x 3.5 oz bottles & 346 x 100-capsule bottles
Pai Shi Tang: 8 x 3.5 oz bottles & 1 x 100-capsule bottle
Xiao Ji Yin Zi: 5 x 3.5 oz bottles
Xin Yi San: 15 x 3.5 oz bottles & 22 x 100-capsule bottles
Yang Yin Xiao Yan Tang: 8 x 3.5 oz bottles & 27 x 100-capsule bottles
.

 
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Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.