December 26, 2000Tegretol(r) (carbamazepine)
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
This is the first public notice of
this Class II
recall issued by FDA.
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).
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.
Novartis Pharmaceutical Corporation, Suffern, New York.
Manufacturer, by letters on September 18, 2000, and November 27, 2000. Firm-initiated
150,223 bottles to 100s and 22,363 bottles of 1000s 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.
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