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May 24, 2000

Digoxin Tablets Recalled

Glasgow, KY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Glaxco Wellcome, Inc. and NCS Health Care, doing business as Vangard Labs Inc., are conducting a recall of Digoxin Tablets, 0.125 mg, repacked in unit dose blister packs (10x31) with and without a grid card, because of tablet thickness failure.

The Digoxin is a prescription indicated for the treatment of mild to moderate heart failure, and for the control of ventricular response rate in patients with chronic atrial fibrillation. The product is coded with the lot number 0547-0003, EXP 1/31/01.

FDA stated in its report that 90 blister pack units were distributed in Pennsylvania, Massachusetts, Illinois, New York, Tennessee, North Carolina, California, Vermont, Maryland, Ohio and Maine.

This ongoing Class III recall was initiated by the company, by letter on April 6. 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-360-0
NDC #00615-0547-63

Notice of this product warning was sent via email to SafeMail subscribers May 24, 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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