Company led drug alert – Docetaxel Injection 160mg /16ml and Docetaxel Injection 20mg / 2ml
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..
Company Contact for medical information enquiries
Pfizer Medical Information, Tel 01304 616161
Published 24 June 2019