February 9, 2001Dilantin Recalled by Pfizer
York, NY (SafetyAlerts) - The Food
and Drug Administration (FDA) said today that Pfizer Inc. is recalling Dilantin 100 MG
Kapseals because of dissolution failure.
This is the first public notice of
this Class III
recall issued by FDA.
DILANTIN 100 MG KAPSEALS (EXTENDED PHENYTOIN SODIUM CAPSULES, USP). ANDA 84-349
NDC N 0071-0362-32, BOTTLES OF 1000'S
NDC N 0071-0362-24, BOTTLES OF 100'S.
Warner Lambert (PARKE-DAVIS)Fajardo, PR.
Pfizer Inc., New York, NY on 12/20/00 via UPS Groung-Tracking Service. Firm-initiated
Nationwide, South Africa and Thailand.
4,032 Bottles of lot 10039F and 40,464 bottles of lot 00299F.
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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