Pfizer UK Recalled Docetaxel Injection 160mg and Docetaxel Injection 20mg

| By | Drug Recall, MHRA, Pfizer
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Pfizer UK Limited is recalling batches as routine stability testing has identified that levels of a known impurity, 10-oxo-docetaxel, may exceed the acceptable level at end of shelf-life.

CLDA Number

CLDA (19)A/04

MDR Number

MDR 73-07/18

Company name

Pfizer UK Limited

Product description

Docetaxel Injection 160mg /16ml Docetaxel Injection 20mg / 2ml

Batch Number/ Expiry

Batch number Strength Expiry Date
S0150518 20mg/2mL 31-Oct-2020
S0390218 160mg/16mL 31-Oct-2020
S0120218 160mg/16mL 31-Oct-2020

Brief Description of Problem

Pfizer UK Limited is recalling the above batches. This is because routine stability testing has identified that levels of a known impurity, 10-oxo-docetaxel, may exceed the acceptable level at end of shelf-life.

SOURCE: gov.uk
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