(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-060-4.
CODE
Lot 852072E25 Lot 852002E21.
RECALLING FIRM/MANUFACTURER
Jam Pharmaceutical, Orange, CA, by letter dated October 17, 2003. FDA initiated recall is ongoing.
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
Unknown.
DISTRIBUTION
Nationwide.
PRODUCT
Kaletra capsules (Lopinavir/Ritonavir), Each soft gelatin capsule contains: Lopinavir 133.3mg, Ritonavir 33.3mg, 180 capsule bottles, Rx only. Recall # D-060-4.
CODE
Lot 852072E25 Lot 852002E21.
RECALLING FIRM/MANUFACTURER
Jam Pharmaceutical, Orange, CA, by letter dated October 17, 2003. FDA initiated recall is ongoing.
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
Unknown.
DISTRIBUTION
Nationwide.
