Company led drug alert - Duavive (conjugated oestrogen/bazedoxifene acetate) 0.45mg/20mg Modified Release Tablets – EU/1/14/960/001

As a precautionary measure, Pfizer Limited is recalling the above batches from wholesalers due to out of specification results from the ongoing stability studies. An evaluation of the foil laminate pouch identified oxygen levels above the specified limits, resulting in lower dissolution results for bazedoxifene acetate.

CLDA Number

CLDA (20)A/02

MDR Number

MDR 142-05/20

Company Name

Pfizer Limited

Product Description

Duavive (conjugated oestrogen/bazedoxifene acetate)

0.45mg/20mg Modified Release Tablets – EU/1/14/960/001

Batch Number/Expiry

  • Batch number: AH1573
    • Expiry date: 08/2021
    • Pack size: 28 tablets
    • First distributed: 12/06/2019
  • Batch number: W96114
    • Expiry date: 09/2020
    • Pack size: 28 tablets
    • First distributed: 04/10/2018

Brief description of problem

As a precautionary measure, Pfizer Limited is recalling the above batches from wholesalers due to out of specification results from the ongoing stability studies. An evaluation of the foil laminate pouch identified oxygen levels above the specified limits, resulting in lower dissolution results for bazedoxifene acetate.

Company Contact for medical information enquiries

For medical information enquiries, please contact: Pfizer Medical Information

Tel: 01304 616161

Email: Medical.Information@pfizer.com

Company Contact for stock enquiries

Remaining stock of these batches should be quarantined and returned to Pfizer for credit.

For stock enquiries, please contact: Pfizer Customer Contact Centre

Tel: 0845 608 8866

Email: Customer.Services@Pfizer.com

Updates to this page

Published 27 May 2020