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June 20, 2000

Vasotec Tablets (Enalapril Maleate) Recalled

Caguas, 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:

  • NDC Numbers: 0006-712-87 and 0006-712-82.

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.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.