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SafetyAlerts
September 6, 2001

Novartis Recalls Tegretol® Tablets.

Suffern, NY  (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Novartis Pharmaceutical Corp., is recalling Tegretol® Tablets (carbamazepine), 200 mg.

This is the first public notice of this Class lI recall issued by the FDA.

RECALL NUMBER, PRODUCT AND CODE:
D-059-1 (Extension to D-059-1) Tegretol® Tablets (carbamazepine), 200 mg, LOT NOS 232E9126?bottles of 1,000 tablets

REASON:
Dissolution failure.

MANUFACTURER/RECALLING FIRM:
Novartis Pharmaceutical Corp., Suffern, NY.

RECALLED BY:
Novartis by letter on August 9, 2001

FIRM INITIATED RECALL:
Ongoing.

DISTRIBUTION:
Nationwide

QUANTITY:
3,238 bottles.

 Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
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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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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.