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November 19,  2003

Recall Update: Dialysist West Kaletra capsules Recall is Complete
 

(SafetyAlerts) - The FDA has released the following information.

PRODUCT
Kaletra capsules (Lopinavir/Ritonavir), Each soft gelatin capsule contains: Lopinavir 133.3mg, Ritonavir 33.3mg, 180 capsule bottles, Rx only. Recall # D-061-4.

CODE
Lot # 852072E25, EXP Date 06/04 Lot #852002E21, EXP Date 12/03 or 2/04.

RECALLING FIRM/MANUFACTURER
Dialysist West, Inc., Tempe, AZ, by letter on August 15, 2003. FDA initiated recall is complete.

REASON
Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and or relabeled bottles is unknown.

VOLUME OF PRODUCT IN COMMERCE
143 units.

DISTRIBUTION
Nationwide.

 
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Health Professional:

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During 2000 there were over
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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.