class 3

Class 3 Medicines Recall: Hikma Farmacêutica Portugal S.A., Gemcitabine 1g/26.3ml & 2g/52.6ml Solution For Infusion Vial, EL(23)A/16

Hikma Farmacêutica Portugal S.A has informed the MHRA of a potential issue impacting the batches listed in this notification.

MDR Number: MDR 002-05/23

Company name: Hikma Farmacêutica Portugal S.A.

Product description:

Gemcitabine 1g/26.3ml Solution For Infusion Vial, PL 15413/0093

Batch number

Expiry date

Pack size

First distributed

CB0013

12/2024

1 vial

20/02/2023

Gemcitabine 2g/52.6ml Solution For Infusion Vial, PL 15413/0093

Batch number

Expiry date

Pack size

First distributed

CB0014

12/2024

1 vial

20/02/2023

Brief description of problem:

Hikma Farmacêutica Portugal S.A has informed the MHRA of a potential issue impacting the batches listed in this notification. Due to a limited number of complaints received regarding loose caps, Hikma Farmacêutica Portugal S.A is recalling the batches as a precautionary measure from pharmacies and wholesalers. The complaints relate to the entire cap being removed when healthcare professionals attempt to remove the flip-off portion of the cap.

Advice to Healthcare Professionals:

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Advice to Patients:

No further action is required by patients as this is a pharmacy and wholesaler-level recall. This product is administered by healthcare professionals directly. If you have concerns about a medicine you may be using, please contact your healthcare professional.

As for all medicines, patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For more information or medical information queries, please contact: 

Portugalcomplaints@hikma.com or Portugaleupharmacovigilance@hikma.com

To access the full recall: Class 3 Medicines Recall: Hikma Farmacêutica Portugal S.A., Gemcitabine 1g/26.3ml & 2g/52.6ml Solution For Infusion Vial, EL(23)A/16