October 29 2003
The Harvard Drug Group Has Recalled Kaletra
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 No. 852072E25.
The Harvard Drug Group, Livonia, MI, by letter dated August 19, 2003.
Firm initiated recall is ongoing.
Counterfeit: bottles labeled as containing Kaletra capsules may contain
Kaletra capsules and/or Agenerase capsules or a mix of both, as well as,
bottles of Kaletra capsules have been repackaged/relabeled by an unknown
source with an extended expiration date/counterfeit lot number.
VOLUME OF PRODUCT IN COMMERCE