July 19, 2001Vira-A Ophthalmic Ointment
TN (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that King Pharmaceuticals Inc. is recalling certain
lot(s) of Vira-A ophthalmic ointment because of stability failure (9 month assay).
This is the first public notice of
this Class II
recall issued by FDA.
Vira-A [Vidarabine Ophthalmic Ointment, USP] 3% sterile ophthalmic ointment; 3.5 gm tubes.
Rx. NDC 61570-367-71 [1 tube cartons and 61570-367-72 [12 tube cartons.]
Warner Lambert Co., Rochester, MI
King Pharmaceuticals, Inc., Bristol TN, contacted NOL-DO by telephone and fax 4/20/01.
FIRM INITIATED RECALL:
Lot.No.5550-1, 39,326 units and Lot No. 53D0-1, 12 units
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 July 19,
2001. For more information regarding the SafetyAlerts free email alert service
please click here.