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SafetyAlerts
July 19, 2001

Vira-A Ophthalmic Ointment Recalled

Bristol, 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.

PRODUCT:
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.]

RECALL NUMBER:
D-261-1

MANUFACTURER
Warner Lambert Co., Rochester, MI

RECALL BY:
King Pharmaceuticals, Inc., Bristol TN, contacted NOL-DO by telephone and fax 4/20/01.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY:
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.

 
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.