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May 28, 2003

Tai Chien Has Recalled Ancom Tablets

(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
Ancom Tablets (Anti-Hypertensive Compound Tablets), 100 count bottles, Manufactured by SHANGHAI PHARMACEUTICALS INDUSTRY CORP. The exterior holding carton is labeled in a similar manner with a paper insert labeled in part as - Ancom Tablet is a complex preparation consisting of anti-hypertensive agents such as rauwolfia alkaloid, dihydralazine sulphate, together with sedative, diuretic, blood-potassium equilibrium salt, etc. Each tablet contains: Reserpine 0.032 mg, Potassium Chloride 30 mg, Hydrochlorothiazide 3.1 mg, Vitamin B1 1 mg, Diazepam 1 mg, Promethiazine HCL 2.1mg, Dihydralazine Sulphate 4.2 mg, Calcium pantothenate 1 mg, Magnesium Trisilicate 30 mg, Vitamin B6 1 mg. The bottle, unit carton & insert are labeled both in English and Chinese. Recall # D-260-3.

CODE
All lots

RECALLING FIRM/MANUFACTURER
Tai Chien, Inc., New York, NY, by press release and recall letter on March 17, 2003. Firm initiated recall is ongoing.

REASON
Unapproved New Drug containing prescription ingredients

VOLUME OF PRODUCT IN COMMERCE
1,850 units.

DISTRIBUTION
NY and Puerto Rico.

 
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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.