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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
May 26, 1998

PRODUCT
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.

Recall #D-145-8.

CODE
Lot #108969C.

MANUFACTURER
Novopharm, Ltd, Scarborough, Ontario, Canada.

RECALLED BY
Novopharm USA, Inc., Schaumburg, Illinois, by telephone on May 5, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Maine, Florida, Louisiana, Pennsylvania, Wisconsin, Missouri, Alabama, South Dakota, Georgia, Ohio, Tennessee, Connecticut, Minnesota.

QUANTITY
1,638 bottles were distributed; firm estimated that 80 percent of the product remained on market at time of recall initiation.

REASON
Incorrect bottle desiccant.

 

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.