May 2020 FDA Recall Drug by Pfizer Inc.
D-1342-2020 - Failed Dissolution Specifications

This Class III drug recall was voluntarily initiated by Pfizer Inc. on May 27, 2020 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1342-2020

Reason for Recall
Failed Dissolution Specifications
Initiated
05-27-2020
Reported
07-01-2020
Quantity
544400 packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85725
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-30-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration 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