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SafetyAlerts
July 18, 2000

Lanoxin Tablets Recalled by Allscripts, Inc.

Libertyville, IL (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Allscripts, Inc. is conducting a recall of Lanoxin tablets because the tablets do not meet thickness specification and therefore may be subpotent.

PRODUCT
Lanoxin Tablets, 0.125 mg, in bottles of 30 and 100, Rx oral cardiotonic indicated for the treatment of mild to moderate heart failure and for the control of ventricular response rate in patients with chronic atrial fibrillation.

Recall #D-418-0.  Class III

CODE
Lot Numbers: 9355140, 0006075, and 9354174.

MANUFACTURER
Glaxo Wellcome, Inc., Zebulon, North Carolina.

RECALLED BY
Allscripts, Inc., Libertyville, Illinois, by letters dated April 17, 2000, and June 7, 2000. Firm-initiated recall ongoing.  This is the first public notice issued by the FDA.

DISTRIBUTION
California, Illinois, Iowa, Wisconsin, Pennsylvania, Arizona, Indiana, Louisiana, Florida, Idaho, Michigan, Hawaii, Maine.

QUANTITY
86 bottles of 30 and 19 bottles of 100 tablets were distributed; firm estimated that 30 percent of the product remained on market at time of recall initiation.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafeMail subscribers July 18, 2000.

 
Selected Recent Recalls


Health Professional:

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

How many did you hear about?

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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.