Pfizer Recalls Duavee Tablets Due to Failed Dissolution Specifications
Pfizer is recalling Duavee tablets because they failed to meet dissolution specifications. The recall covers 544,400 packages distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classifies this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or specification issues without reported harm.
Plain-English summary
Pfizer Inc. is recalling Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg due to failed dissolution specifications. The affected product is packaged in 2 blister cards containing 15 tablets each (30 tablets total) and is distributed by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer. The medication is made in Ireland and carries the NDC 00008-1123-12.
The recall involves 544,400 packages distributed nationwide within the United States. Specific lot numbers and expiration dates are listed in the recall documentation, including lots AF7814, AH6565, AP5189, CG8921, CL6603, DH5847, T17703, T99214, W46878, X07330, and X99074.
Consumers with this medication should contact their healthcare provider for guidance on alternative treatment options. The FDA classifies this recall as Class III, indicating that the product is not likely to cause adverse health consequences.
The recalled product
- 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
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 544,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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
Distributed nationwide across the United States.
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