Why it was recalled
Failed Dissolution Specifications
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1342-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 27, 2020
- FDA report date
- Jul 1, 2020
- Quantity
- 544400 packages
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1342-2020, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 85725
- Address
- 235 E 42nd St
- 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
- Postal code
- 10017-5703
- Report date
- Jul 1, 2020
- Product type
- Drugs
- Recall number
- D-1342-2020
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 544400 packages
- Termination date
- Jun 30, 2023
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 27, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 24, 2020