March 21, 2000Novartis Pharmaceuticals Recall
Voltaren-XR Extended Release Tablets
Suffern, NY (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Novartis Pharmaceuticals is recalling
Voltaren(r)-XR Extended Release Tablets because of dissolution failure (release rate) at 4
and 8 hour time periods.
Voltaren(r)-XR Extended Release
Tablets (Diclofenac Sodium), 100 mg, in 100 count bottles, is a prescription used for
chronic therapy of osteoarthritis and rheumatoid arthritis, and for the treatment of
According to the FDA, approximately
9,750 bottles were distributed nationwide and bear the Lot Number of 104A7322 - EXP 9/01.
This ongoing Class III recall
was initiated by Novartis Pharmaceuticals, Inc., by fax on December 29, 1999. 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-251-0
Notice of this product warning was
sent via email to SafeMail
subscribers March 21, 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.