Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Dissolution Specifications
Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Reason Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Reason CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Reason CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Reason Labeling:Label Mixup; ESTERIFIED ESTROGENS, Tablet, 0.625 mg may be potentially mislabeled as ETODOLAC, Tablet, 400 mg, NDC 51672401801, Pedigree…
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