Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences

SafetyAlerts
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.

 
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?

Sign-up for SafetyAlerts by Email -
The free internet newsletter that could
some day literally save your life - or
the life of someone you know.

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.

###

 

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.