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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
December 23, 1998

PRODUCT
Requip(tm) Tablets (Ropinirole Hydrochloride), 0.25 mg, in patient starter packages (126 tablets), Rx used for treatment of signs and symptoms of idiopathic Parkinson's disease. NDC #489061. Recall #D-041-9.

CODE
Lot numbers: 680970 EXP 2/99 and 680990 EXP 2/99.

MANFACTURER
Smith Kline Beecham Pharmaceuticals, West Sussex, United Kingdom.

RECALLED BY
Smith Kline Beecham Pharmaceuticals, Philadelphia, Pennsylvania, by letter sent the week of September 28, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
5,730 packages of lot 680970 and 5,695 packages of lot 680990 were distributed. Firm estimates none remain on the market.

REASON
Degradation test data will not support labeled expiration date.

 

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.