(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-013-4.
CODE
Lot No. 852072E25.
RECALLING FIRM
The Harvard Drug Group, Livonia, MI, by letter dated August 19, 2003.
Firm initiated recall is ongoing.
MANUFACTURER--unknown
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
71 bottles.
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-013-4.
CODE
Lot No. 852072E25.
RECALLING FIRM
The Harvard Drug Group, Livonia, MI, by letter dated August 19, 2003.
Firm initiated recall is ongoing.
MANUFACTURER--unknown
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
71 bottles.
DISTRIBUTION
Nationwide.
