|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
May 26, 1998
Ranitidine Tablets, USP (Ranitidine Hydrochloride), 150 mg, in 500 tablet bottles,
Rx for the short-term treatment of active duodenal ulcer. NDC #55953-544-70.
Novopharm, Ltd, Scarborough, Ontario, Canada.
Novopharm USA, Inc., Schaumburg, Illinois, by telephone on May 5, 1998.
Firm-initiated recall ongoing.
Maine, Florida, Louisiana, Pennsylvania, Wisconsin, Missouri, Alabama, South
Dakota, Georgia, Ohio, Tennessee, Connecticut, Minnesota.
1,638 bottles were distributed; firm estimated that 80 percent of the product
remained on market at time of recall initiation.
Incorrect bottle desiccant.