Wyeth Pharmaceuticals: FAILED USP DISSOLUTION TEST REQUIREMENT. An out-of-specification result for NDA conjugated estrogens was obtained for Prempro 0.45mg/1.5 mg tablets, Lot A66957, during testing under the firm's Dissolution Surveillance Program (see complete reason for recall).; FAILED USP DISSOLUTION TEST REQUIREMENT. An out-of-specification result for NDA conjugated estrogens was obtained for Prempro 0.3mg/1.5 mg tablets, Lot B13132, during testing under the firm's Dissolution Surveillance

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Sources: FDA iRES · Raw API Response

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