Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Duavee (conjugated estrogens/bazedoxifene)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Dissolution Specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
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 NDC
0008-1123-12
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Duavee conjugated estrogens/bazedoxifene NDC 00008-1123 |
ESTROGENS, CONJUGATED .45 mg/1; BAZEDOXIFENE ACETATE 20 mg/1 | Tablet, Film Coated Oral |
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Rx |
- Recalling firm
- Pfizer Inc.
- NDC code
- 00008-1123-12
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1342-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Pfizer Inc.
All 2020 recalls
Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Vial Label: Epinephrine Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Levoxyl (levothyroxine sodium tablets, USP)
Subpotent drug
Other dissolution failure recalls from 2020
All dissolution failure recalls
Class II · Moderate risk
Vumerity (diroximel fumarate)
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg
Failed Dissolution Specifications
Class I · High risk
Anagrelide Capsules
Failed Dissolution Specifications
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