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SafetyAlerts
December 26, 2000

Tegretol(r) (carbamazepine) Recalled

Suffern, NY (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Novartis Pharmaceutical Corporation is recalling Tegretol(r) (carbamazepine), 200 mg, in 100 and 1,000 unit bottles because of dissolution failure.

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

PRODUCT
Tegretol(r) (carbamazepine), 200 mg, in 100 and 1,000 unit bottles, Rx product indicated for use as an anticonvulsant associated with epilepsy.

NDC #0083-0027-30 (100) and
NDC 0083-0027-40 (1000).

Recall #D-059-1.

CODE
Lot Numbers: 128B1120 EXP 6/02, 156B3063 EXP 10/02, 158B3063 EXP 10/02,
170D4247 EXP 1/03, 121B9991 EXP 4/02, 137B1238 EXP 6/02, 144B1825 EXP
8/02, 150B2289 EXP 1/02, 155B2289 EXP 10/02, and 1T237018 EXP 9/01.

MANUFACTURER
Novartis Pharmaceutical Corporation, Suffern, New York.

RECALLED BY
Manufacturer, by letters on September 18, 2000, and November 27, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
150,223 bottles to 100’s and 22,363 bottles of 1000’s were distributed.

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

Notice of this product warning was sent via email to SafetyAlerts subscribers December 26, 2000.  For more information regarding the SafetyAlerts free email alert service please click here.

 
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?

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