May 28, 2003
Tai Chien Has Recalled Ancom Tablets
The Food and Drug Administration (FDA) released the following information.
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.
Tai Chien, Inc., New York, NY, by press release and recall letter on March
17, 2003. Firm initiated recall is ongoing.
Unapproved New Drug containing prescription ingredients
VOLUME OF PRODUCT IN COMMERCE
NY and Puerto Rico.