February 9, 2001Novaritis Expands Tegretol
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.
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,
Recall # EXTENSION TO D-059-1.
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
179D5121 (EXP. 2/2003) in bottles of 100s
179D5216 (EXP. 2/2003) in bottles of 1000s.
Novartis Pharmaceutical Corp. (Suffern, NY).
Manufacturer, by letters on 9/18.00. and 11/27/00 (expansion). Firm-initiated recall
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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