Pfizer Recalls Batches of Docetaxel Injection

Pfizer has issued a voluntary recall of batches of its docetaxel injection 80 mg/8 mL due to impurity concerns.

According to an announcement by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Oct. 22, 2019, Pfizer has issued a voluntary recall of batches of its docetaxel injection 80 mg/8 mL due to impurity concerns.

The specific batches to be recalled are S0130118 and S0140518, as specified on MHRA’s website. Pfizer’s reasoning for the recall is that during routine stability testing, impurity, 10-oxo-docetaxel, was identified at potentially unacceptable levels towards the end of the product’s shelf-life.

This latest recall follows from the company’s earlier recall of batches of docetaxel injection 160 mg/16 mL and docetaxel injection 20 mg/2 mL in June 2019. The earlier recall was also a result of potentially unacceptable levels of 10-oxo-docetaxel at the end of shelf-life.

Source: MHRA