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Pfizer recalls HRT batches over packaging concerns

Pfizer is recalling two batches of its oestrogen replacement product Duavive due to concerns around faulty packaging, the Medicines and Healthcare products Regulatory Agency (MHRA) has said.

The recall, which was announced today as a precautionary measure, affects batches AH1573 (expiry date August 2021) and W96114 (September 2020) of 28-size packs of Duavive 0.45mg/20mg modified release tablets.

During the manufacturer’s stability studies “an evaluation of the foil laminate pouch identified oxygen levels above the specified limits, resulting in lower dissolution results for bazedoxifene acetate,” explained the MHRA.

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




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