May 24, 2000Digoxin Tablets Recalled
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
Notice of this product warning was
sent via email to SafeMail
subscribers May 24, 2000.
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