November 26, 2003
Jam Pharmaceutical Has Recalled
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 Lot 852002E21.
Jam Pharmaceutical, Orange, CA, by letter dated October 17, 2003. FDA
initiated recall is ongoing.
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