Halsey Drug Co.
Generic drug manufacturer receives FDA warning letter on July 10 regarding the sale of terpin hydrate/codeine elixir as an OTC expectorant and antitussive. Terpin hydrate is not a Category I ingredient in FDA's final monongraph for expectorants published on Feb. 28, 1989. According to the firm's legal counsel, Scott Bass, Halsey had already withdrawn the product from the market before the FDA letter was sent. In addition, Bass said Halsey had won a contract to supply the product to the Defense Employee Support Commission last year and has been asked to submit a bid for the same contract this year. FDA will soon decide whether to seek a Class III recall.
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