June 20, 2000Vasotec Tablets (Enalapril
Puerto Rico (SafetyAlerts) - The
Food and Drug Administration (FDA) today reported that Merck Manufacturing Division is
conducting a recall of Vasotec Tablets (Enapril Maleate) 5 mg, in 1,000 and 10,000 tablet,
because of low dissolution failure.
Vasotec Tablets are indicated for the
treatment of hypertension, it is also indicated for the treatment of symptomatic
congestive heart failure usually in combination with diuretics and digitalis.
The affected products are:
The affected products are coded with
Lot Numbers: K0634 EXP 12/01 and K0635 EXP 12/01. The recalled products were distributed
in Florida, Nevada, New Mexico, Texas, Arizona, South Dakota, Illinois. Approximately 149
units were distributed.
This ongoing Class III recall
was initiated by the company, by letter dated March 12, 2000. This is the first
public notice issued by the FDA.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #D-396-0
Notice of this product warning was
sent via email to SafeMail
subscribers June 20, 2000.
Safety Alerts compiles
comprehensive safety recall information for the United States. SafeMail is a free email
service to warn consumers of faulty products and contaminated foods. For complete
information regarding current recalls, past recalls and timely product warning
notification visit: www.safetyalerts.com.