FDA recall D-1342-2020

Product

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

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2020-05-27

Report date

2020-07-01

Termination date

2023-06-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1342-2020