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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

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

PRODUCT
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. Recall #D-018/019-9.

CODE
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.

MANUFACTURER
Hoechst Marion Roussel, Inc. Kansas City, Missouri.

RECALLED BY
Manufacturer, by letter dated September 18, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
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.

REASON
Bottle defects and/or glass fragments in the product(s).

 

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.