July 11, 2001Phenytoin Sodium Recalled
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.
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
NDC#0172-2057-60, ANDA# -- 80-259, Product code is
#2057, Lot Number is 268 Exp. 2/01
DISSOLUTION FAILURE (18 MONTH STABILITY)
Zenith Goldline Pharmaceuticals Northvale, NJ
The recalling firm sent recall letter dated 1/10/01 to all direct accounts.
FIRM INITIATED RECALL:
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.