Paclitaxel 6mg/ml concentrate for solution for infusion; 100mg in 16.7ml - exterior of vials potentially contaminated with Methotrexate

(Hospira UK Limited) Paclitaxel 6mg/ml concentrate for solution for infusion; 100mg in 16.7ml - risk of the exterior of vials contaminated with Methotrexate (EL (16)A/05)

24 May 2016

Class 4 medicines defect information

Caution in Use

Distribute to Hospital Pharmacy Level

MDR 06-05/16

Product details

Hospira UK Limited

Paclitaxel 6mg/ml concentrate for solution for infusion; 100mg in 16.7ml

PL 04515/0159

Batch Number Expiry date Pack Size First distributed
C016841AE Jan 2017 1 x 16.7ml 6 May 2015

Alert details

Following the investigation of a breakage on the line used for packing the above batch of Paclitaxel, it has become apparent that there is a theoretical risk of contamination of the exterior of vials from this batch with Methotrexate. The quality of the product contained in the vials is not impacted.

There is a potential risk of harm from this incident, therefore recipients of this Alert are asked to bring it to the attention of any Healthcare Professional who handles Paclitaxel, whether dispensing or preparing for administration. Safety precautions, such as wearing gloves, should be taken when handling vials from this batch.

If a contaminated vial is found, or for any medical advice, please contact Hospira Medical Information team on 0800 088 5133

For information on product availability, please contact Hospira Customer Service on 0800 028 7304

Recipients of this Drug Alert should bring it to the attention of relevant contacts.

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Hospira UK Limited - Paclitaxel concentrate for solution for infusion EL (16)A05

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