March 18, 2003
Tai Chien Has Recalled Ancom
Anti-Hypertensive Compound Tablets
New York, NY (SafetyAlerts)
The Food and Drug
Administration (FDA) said that Tai Chien Inc. has recalled all 100-tablet
bottles of Ancom Anti-Hypertensive Compound Tablets, an unapproved new drug
labeled to contain several prescription drug ingredients, including
reserpine, diazepam, promethiazine, and hydrochlorothiazide. The sale of a
product with this combination of ingredients poses possible serious health
risks including sedation, depression, and potentially life-threatening
abnormalities of the blood.
This recall includes all lot codes of the product remaining on the market.
Ancom Tablets were sold without prescriptions to consumers at Tai Chien's
retail establishment in New York City. Product was also sold to a
distributor in Puerto Rico.
Ancom Tablets are labeled for anti-hypertensive use and are packaged in
white plastic bottles of 100 tablets bearing blue and white lettered
labeling. Each bottle is sold in an outer cardboard holding carton. Both the
carton and immediate container label bear the product name as Ancom tablets,
Anti-hypertensive Compound, and display the manufacture's name as Shanghai
Pharmaceutical Industry Corp., Shanghai, China. The labeling also bears
Chinese markings, which appear to be dual declarations. The holding carton
is white with a pink and blue vertical stripe bearing blue and white
lettering. The product carton also includes a pre-printed insert labeled
with an ingredient statement and directions for use.
At least one illness has been reported to date. Consumers who have used this
product and are experiencing any adverse reactions should seek advice from
their physician for appropriate evaluation and treatment of their
Consumers who purchased Ancom Anti-Hypertensive Compound Tablets are urged
to immediately discontinue use of the product and return it to the place of
purchase for a full refund.
Consumers with questions may contact the company at 1-212-431-5636.
This recall is being conducted in cooperation with the U.S. Food and Drug