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SafetyAlerts
July 11, 2001

Phenytoin Sodium Recalled

Northvale, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Zenith Goldline  Pharmaceuticals of Northvale, NJ is recalling certain lot(s) of Phenytoin Sodium 100mg, Prompt Release   Capsules - as described below - because of dissolution failue.

Phenytoin Sodium
is an anticonvulsant used to treat seizures. It may also be used to treat other conditions as determined by your doctor.
.

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

PRODUCT AND CODE:
Phenytoin Sodium 100mg, Prompt Release Capsules, Zenith Goldline, Label, 100 count bottles,

RECALL NUMBER
D-239-1

NDC#0172-2057-60, ANDA# -- 80-259, Product code is #2057, Lot Number is 268 Exp. 2/01

REASON:
DISSOLUTION FAILURE (18 MONTH STABILITY)

MANUFACTURER/RECALLING FIRM:
Zenith Goldline Pharmaceuticals Northvale, NJ

RECALLED BY:
The recalling firm sent recall letter dated 1/10/01 to all direct accounts.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY
18,963 bottles.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
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.