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SafetyAlerts
January 17, 2002

Janssen Has Recalled Risperdal (Risperidone)Tablets

Titusville, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said that Pharmaceutical Sourcing Group Americas (Janssen ) has initiated a class three recall for Risperdal (Risperidone)Tablets, 0.25mg, bottles of 60 and 500 tablets. Rx only Risperdal tablets, 0.25mg, are a prescription benzisoxazoleantipsychotic agent in a solid dosage form intended for the management of the manifestations of psychotic disorders.

PRODUCT
Risperdal (Risperidone)Tablets, 0.25mg, bottles of 60 and 500  tablets. Rx only Risperdal tablets, 0.25mg, are a prescription benzisoxazole antipsychotic agent in a solid dosage form intended for the management of the manifestations of psychotic disorders, Recall # D-078-2.

CODE
Lot Number -- Expiration Date
NDC number 50458-301-04 and 50458-301-50
500'S
90P0550 -- 3/31/02
90P0739 -- 3/31/02
90P0775 -- 9/30/02
91P0112E -- 9/30/02
91P0003 -- 10/31/02
91P0161 -- 12/31/02
91P0223 -- 1/31/03
91P0372 -- 1/31/03
91P0471 -- 3/31/03
91P0415 -- 3/31/03
91P0582 -- 3/31/02
91P0640E -- 3/31/03
91P1011 -- 5/31/03
91P1053E -- 5/31/03
91P0883 -- 5/31/03
60'S
90P0746E -- 9/30/02
90P0795E -- 9/30/02
91P0113 -- 10/31/02
91P0002 -- 10/31/02
91P0206E -- 12/31/02
91P0369 -- 1/31/03
91P0468E -- 1/31/03
91P0414 -- 3/31/03
91P0575E -- 3/31/03
91P0614E -- 3/31/03
91P0661E -- 3/31/03
91P0898 -- 5/31/03
91P0840 -- 5/31/03
91P1009 -- 5/31/03
91P1067E -- 6/30/03.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Pharmaceutical Sourcing Group Americas (Janssen )Titusville, NJ ,by letter on 11/30/2001. Manufacturer: Janssen-Cilag S.P.A Latina, Italy. Firm initiated recall is ongoing.

REASON
Dissolution failure.

VOLUME OF PRODUCT IN COMMERCE
496370 bottles of 60's;
40925 bottles of 500.

DISTRIBUTION
Nationwide
.

 
Selected Recent Recalls


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.