Teva Pharmaceuticals USA, Inc.: Failed USP Dissolution Test Requirements; For lot 0912T16A stability testing yielded OOS results for dissolution at stage 3, 4-hour time point with an average result of 43% ranging from 37-51% (average spec 44-67%).; Failed USP Dissolution Test Requirements; Stability testing revealed an out of specification (OOS) result for dissolution at 1 hour for lot 0905T12A, average result of 9% (spec 10-30%). For lot 0908T06A stability testing yielded OOS results for diss

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Sources: FDA iRES · Raw API Response

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