|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
November 18, 1998
a) Hoechst Marion Roussel Carafate (sucralfate) Suspension containing 1 g.
sucralfate per 10 mL, for oral administration, packaged in 14-fluid ounce glass bottles,
Rx, indicated for the short-term treatment of active duodenal ulcer, NDC #0088-1700-15; b)
Hoechst Marion Roussel Ditropan (oxybutynin chloride) Syrup containing 5 mg. oxybutynin
chloride per 5 mL., for oral administration, packaged in 16-fluid ounce glass bottles, Rx,
indicated for the relief of symptoms of bladder instability associated with voiding in
patients with uninhibited neurogenic or reflex neurogenic bladder, NDC #0088-1373-8.
Lot numbers: a) 98062379, EXP 07/08/2000, 98062618, EXP 07/14/2000, 98062619, EXP
07/15/2000, 98062748, EXP 07/21/2000, 98062749, EXP 07/22/2000, 98062752, EXP 08/04/2000,
98062753, EXP 08/05/2000, 98064111, EXP 08/18/2000, 98064112, EXP 08/19/2000, 98066839,
EXP 10/13/2000; b) 98063621, EXP 07/31/2000.
Hoechst Marion Roussel, Inc. Kansas City, Missouri.
Manufacturer, by letter dated September 18, 1998. Firm-initiated recall ongoing.
a) 229,528 bottles; b) 9,767 bottles were distributed; firm estimated that 5 percent of
product remained on market at time of recall initiation.
Bottle defects and/or glass fragments in the product(s).