Medicine recall 24 May 2016

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

Yes – this has been recalled
The problem
(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)
What to do
Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.
Source: Medicines and Healthcare products Regulatory Agency (MHRA) Official notice ↗

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: C016841AE
  • Expiry date: Jan 2017
  • Pack size: 1 x 16.7ml
  • First distributed: 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

Updated 24 May 2016. This page summarises an official notice. Details can change – always follow the official notice.

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