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SafetyAlerts
February 9, 2001

Dilantin Recalled by Pfizer

New 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.

PRODUCT
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.

Recall #D-086-1.

CODE:
LOT NO. EXP. DATE
10039F 2/01
00299F 8/01

MANUFACTURER;
Warner Lambert (PARKE-DAVIS)Fajardo, PR.

RECALLED BY:
Pfizer Inc., New York, NY on 12/20/00 via UPS Groung-Tracking Service. Firm-initiated recall ongoing.

DISTRIBUTION:
Nationwide, South Africa and Thailand.

QUANTITY:
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.

 
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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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.