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SafetyAlerts
October 29 2003

The Harvard Drug Group Has Recalled Kaletra capsules

(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
.

 
Selected Recent Recalls


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During 2000 there were over
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.