|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
February 18, 1998
Gliadel Wafer (Polifeprosan 20 with Carmustine
Implant), 7.7 mg carmustine/wafer, in units of
8 wafers individually packaged, Rx indicated
for use as a adjunct to surgery to prolong
survival in patients with recurrent
glioblastoma multiform for whom surgical
resection is indicated. NDC #IS 0075-9995-0107.
Lot #K97A1 and #K97B4..
Guilford Pharmaceuticals, Inc., Baltimore,
Rhone Poulenc Rorer Pharmaceuticals, Inc.,
Collegeville, Pennsylvania, by telephone on
December 12, 1997, followed by letter dated
December 16, 1997. Firm-initiated recall
QUANTITY 41 units (8 wafers each) and 17 partial units
(less than 8 wafers) remained on market at
time of recall initiation.
Excess breakage of wafers.