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SafetyAlerts
February 9, 2001

Novaritis Expands Tegretol Recall

Suffern, NY (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Novartis Pharmaceutical Corp. has expanded its recall of TegretolÆ (carbamazepine USP), 200 mg tablets, in bottles of 100 and 1,000 tablets because of dissolution failure.

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

PRODUCT:
TegretolÆ (carbamazepine USP), 200 mg tablets, in bottles of 100 and 1,000 tablets. This Rx product is indicated for use as an anticonvulsant associated with epilepsy.

100 tablets:NDC 0083-0027-30, #6505-00-232-5046. 1000 tablets: NDC 0083-0027-40, #6505-00-408-8915

Recall # EXTENSION TO D-059-1.

CODE:
LOT NOS. Initial lots recalled on 9/18/00:
150B2289 (10/2002), 155B2289 (10/2002),

121B9991 (4/2002),128B1120 (6/2002),
137B1238 (6/2002), 144B1825 (8/2002),
156B3063 (10/2002),158B3063 (10/2002),
170D4247 (1/2003), 1T237018 (9/2001).

*** ADDITIONAL LOTS included in recall expansion of 11/17/00:
179D5121 (EXP. 2/2003) in bottles of 100s
179D5216 (EXP. 2/2003) in bottles of 1000s.

MANUFACTURER:
Novartis Pharmaceutical Corp. (Suffern, NY).

RECALLED BY:
Manufacturer, by letters on 9/18.00. and 11/27/00 (expansion). Firm-initiated recall ongoing.

DISTRIBUTION:
Nationwide.

QUANTITY:
A total of 172,586 bottles (150,223 bottles of 100s and
22,363 bottles of 1000s) for the 10 initial lots of recalled TegretolÆ 200 mg were distributed (by lot) as follows:
Lot #150B2289: 3784 bottles of 1000s
Lot #155B2289: 3787 bottles of 1000s
Lot #121B9991: 3641 bottles of 1000s
Lot #128B1120: 36,734 bottles of 100s
Lot #137B1238: 3750 bottles of 1000s
Lot #144B1825: 3756 bottles of 1000s
Lot #156B3063: 37,444 bottles of 100s
Lot #158B3063: 38,137 bottles of 100s
Lot #170D4247: 37,908 bottles of 100s
Lot #1T237018: 3645 bottles of 1000s   
*** Additional 2 lots:
Lot #179D5216: 2689 bottles of 1000s were distributed between 9/11/00 and 10/23/00
Lot #179D5121: 11,047 bottles of 100s were distributed between 4/26/00 and 5/5/00.

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 February 9, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

 
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Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.