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Halsey Drug

Executive Summary

Company reports March 30 that "a variety of problems have been identified with certain of the company's products which relate primarily to record-keeping practices as well as the addition of unapproved active ingredients and processing deviations." Problems were discovered during an ongoing investigation carried out by the company, the Department of Justice and FDA into Halsey's pending and approved ANDAs. Halsey says it has stopped "production and sale of a number of products" and is recalling at least three products.
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PS022388

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