Drug 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
D-1342-2020
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 85725
- Status
- Terminated
- Classification
- Class III
- Quantity
- 544400 packages
- Official record key
drug-enforcement:D-1342-2020
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: AF7814, 2021 AUG 31; AH6565, 2021 SEP 30, AP5189, 2020 SEP30; CG8921, 2022 FEB 28; CL6603, DH5847, 2022 MAR 31; T17703, T99214 2020 JUN 30, W46878, X07330, 2020 SEP 30; X99074, 2021 JUN 30
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications