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March 21, 2000

Novartis 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 ankylosing spondylitis..

According to the FDA, approximately 9,750 bottles were distributed nationwide and bear the Lot Number of 104A7322 - EXP 9/01. (NDC 0028-0205-01)

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.

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Health Professional:

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During 2000 there were over
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