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Safety Alerts
July 27, 1999

Solvay Pharmaceuticals Recalls Rowasa Rectal Suppositories

Marietta, GA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Solvay Pharmaceuticals is recalling Rowasa Rectal Suppositories because of dissolution failure and/or lack of assurance of stability through labeled expiry date.

PRODUCT
Rowasa Rectal Suppositories (Mesalamine, 500 mg), in cartons of 12, 24, and physician sample of 2's, Rx indicated for the treatment of active ulcerative proctitis.

Recall #D-282-9.

CODE
All lot numbers remaining within expiration date.

MANUFACTURER
G&W Laboratories, Plainfield, New Jersey (contract manufacturer).

RECALLED BY
Solvay Pharmaceuticals, Marietta, Georgia, by letter mailed on May 18, 1999, and by voice mail on May 11, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
307,137 cartons of 12; 254,946 cartons of 24;and 100,281 pyhysician samples were distributed.

 

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.