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