April 30, 2003
Best Life International Has Recalled
The Food and Drug
Administration (FDA) released the following information.
Ancom tablets, Anti-hypertensive Compound Tablets, 100 count bottle. 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 2.1 mg, Dihydralazine Sulphate 4.2 mg, Calcium pantothenate 1 mg,
Magnesium Trisilicate 30 mg, Vitamin B6. The bottle, unit carton & insert
are labeled both in English and Chinese. Recall # D-234-3.
All lot codes.
Recalling Firm: Best Life International, Incorporated, Mayaguez, PR, by
letter, on February 11, 2003.
Manufacturer: Shanghai Pharmaceutical Industry Corp. Shanghai, China. FDA
initiated recall is ongoing.
Unapproved New Drug containing several prescription ingredients.
VOLUME OF PRODUCT IN COMMERCE