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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
February 24, 1999

PRODUCT
Rowasa Suppository-rectal (Mesalamine), 500 mg, in packages of 2 (physician sample), 12, & 24, rectal suppository for the treatment of active ulcerative proctitis. Recall #D-113-9.

CODE
Lot numbers: 88787, 89030, 88860, 88788, 89029, 89028, 89027, 88859, 88785, 88786.

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

RECALLED BY
Solvay Pharmaceuticals, Inc., Marietta, Georgia, by letter dated December 4, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

186,602 units were distributed.

REASON
Product failed dissolution testing (stability).

 

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.