Recalls / Class III
Class IIID-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
- Affected lot / code info
- 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
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 544400 packages
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-05-27
- FDA classified
- 2020-06-24
- Posted by FDA
- 2020-07-01
- Terminated
- 2023-06-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1342-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.