November 19, 2003
Recall Update: Dialysist West Kaletra
capsules Recall is Complete
The FDA has released the following information.
Kaletra capsules (Lopinavir/Ritonavir), Each soft gelatin capsule contains:
Lopinavir 133.3mg, Ritonavir 33.3mg, 180 capsule bottles, Rx only. Recall #
Lot # 852072E25, EXP Date 06/04 Lot #852002E21, EXP Date 12/03 or 2/04.
Dialysist West, Inc., Tempe, AZ, by letter on August 15, 2003. FDA initiated
recall is complete.
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