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10/1/2003

Wholesaler Recalls Counterfeit HIV Drug

Cheryl Thompson

Bottles labeled as containing capsules of the combination product Kaletra, used in the treatment of human immunodeficiency virus infection, may contain a different antiretroviral agent or bear a false expiration date and counterfeit lot number, according to a weekly enforcement report from the Food and Drug Administration (FDA).

The Sept. 24 report stated that Morris & Dickson Co. Ltd., a wholesaler in Shreveport, La., on Aug. 1 initiated a recall of 58 Kaletra-labeled bottles that the company had distributed across the country.

According to FDA, Morris Dickson reported that the 58 bottles may contain Agenerase capsules instead of Kaletra capsules. The bottles were apparently repackaged or relabeled by an unknown source, which applied labels bearing an expiration date later than the manufacturer's date and a counterfeit lot number.

Abbott Laboratories manufactures Kaletra, containing 133.3 mg of lopinavir and 33.3 mg of ritonavir apiece. The capsules are orange and made of soft gelatin.

Agenerase is a product of GlaxoSmithKline. The off-white capsules are made of soft gelatin and contain 150 mg of amprenavir.