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.