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SafetyAlerts
December 08, 1999

SmithKline Beecham Pharmaceuticals  Requip (Ropinirole Hydrochloride) Recalled

Philadelphia, PA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that SmithKline Beecham Pharmaceuticals is recalling Requip (Ropinirole Hydrochloride) sold in bottles of 100, 1mg tablets, as a prescription for the treatment of Parkinsonís disease.  The tablets have been found to fade from green to yellow, making it difficult to distinguish between strengths or could cause the wrong product to be dispensed.

This ongoing Class III recall was initiated by the company, October 6, 1999 by letter.  This is the first notice the FDA has issued to the general public of the recall.

Approximately 20,000 bottles, NDC #0007-4892-20, were distributed nationwide and bear the following lot numbers and experation dates:

716550  9/30/99
716410  10/31/99
716420  10/31/99
716560  10/31/99
717810  1/31/00
769070  6/30/00
768910  6/30/00
769340  6/30/00
779810  6/30/00
779820  6/30/00
779830  6/30/00
779840  7/31/00
002446  11/30/99
002447  11/30/99
003351  1/30/00
003352  1/31/00
004019  2/28/00
004102  2/28/00
004906  3/31/00
004907  3/31/00
005399  4/30/00
005727  4/30/00
006293  4/30/00
006294  4/30/00
007003  5/31/00
007004  5/31/00
007496  5/31/00
007497  5/31/00
007816  5/31/00
007902  5/31/00
007817  6/30/00
007903  6/30/00

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

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Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.