April 30, 2003
Recall Update: Herbsland Incorporated Recall is
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-233-3.
All lot codes.
Recalling Firm: Herbsland Incorporated, New York, NY, by visit, on November
Manufacturer: Shanghai Pharmaceutical Industry Corp. Shanghai, China. FDA
initiated recall is complete.
Unapproved new drug labeled to contain several prescription drug
ingredients, including reserpine, diazepam, promethiazine, and
VOLUME OF PRODUCT IN COMMERCE