The FDA has released the following information.
PRODUCT
Kaletra Capsules (lopinavir/ritonavir) capsules, Each soft gelatin capsule contains: Iopinavir 133.3mg, ritonavir 33.3mg, 180 Capsules bottles, Rx only, Abbott Laboratories, North Chicago, IL. Recall # D-320- 3.
CODE
Lot No. 852072E25, Expiration Date June 2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Morris Dickson, Shreveport, LA, by telephone on August 1, 2003. Manufacturer: Unknown. Firm initiated recall is ongoing.
REASON
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
58 bottles of 180 capsules.
DISTRIBUTION
Nationwide.
PRODUCT
Kaletra Capsules (lopinavir/ritonavir) capsules, Each soft gelatin capsule contains: Iopinavir 133.3mg, ritonavir 33.3mg, 180 Capsules bottles, Rx only, Abbott Laboratories, North Chicago, IL. Recall # D-320- 3.
CODE
Lot No. 852072E25, Expiration Date June 2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Morris Dickson, Shreveport, LA, by telephone on August 1, 2003. Manufacturer: Unknown. Firm initiated recall is ongoing.
REASON
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
58 bottles of 180 capsules.
DISTRIBUTION
Nationwide.
