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Uristat retail recall

This article was originally published in The Tan Sheet

Executive Summary

Johnson & Johnson division McNeil will replace Actavis as manufacturer of its Uristat OTC urinary tract infection tablets after finding problems in Actavis' manufacturing operations. Iceland-based Actavis' U.S. division, Morristown, N.J.-based Actavis Totowa, initiated a retail level recall of Uristat on June 16, McNeil said, adding that no safety problems were reported and the product is not being recalled from consumers. However, because of problems McNeil found in Actavis' manufacturing - concerning "stability indicating methods" used to confirm that a product "performs as intended over its established shelf life" - McNeil said it terminated its contract with the company. McNeil said Uristat will not be available until it hires another manufacturing firm. The Fort Washington, Pa.-based company, which has marketed Uristat since 1996, said it does not have a timetable to return Uristat to market...
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