Pharmaceuticals Recalls Rowasa Rectal Suppositories
July 27, 1999
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.
Rowasa Rectal Suppositories (Mesalamine, 500 mg), in
cartons of 12, 24, and physician sample of 2's, Rx indicated for the treatment of active
All lot numbers remaining within expiration date.
G&W Laboratories, Plainfield, New Jersey (contract manufacturer).
Solvay Pharmaceuticals, Marietta, Georgia, by letter mailed on May 18, 1999, and by
voice mail on May 11, 1999. Firm-initiated recall ongoing.
Nationwide and Puerto Rico.
307,137 cartons of 12; 254,946 cartons of 24;and 100,281 pyhysician samples were