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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
February 18, 1998

PRODUCT
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.

Recall #D-065-8.

CODE

Lot #K97A1 and #K97B4..

MANUFACTURER

Guilford Pharmaceuticals, Inc., Baltimore,
Maryland.

RECALLED BY

Rhone Poulenc Rorer Pharmaceuticals, Inc.,
Collegeville, Pennsylvania, by telephone on
December 12, 1997, followed by letter dated
December 16, 1997. Firm-initiated recall
ongoing.

DISTRIBUTION

Nationwide.
QUANTITY 41 units (8 wafers each) and 17 partial units
(less than 8 wafers) remained on market at
time of recall initiation.

REASON

Excess breakage of wafers.

 

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.