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

Source: MHRA /Gov.uk 10th May 2023

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 name

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

SNOMED Code

326910007

Active Pharmaceutical Ingredient: gemcitabine

Product name

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

SNOMED Code

17844811000001107

Active Pharmaceutical Ingredient: gemcitabine

Brief description of the 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 for 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 for 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.

Further Information

For more information or medical information queries, please contact: Portugalcomplaints@hikma.com or Portugaleupharmacovigilance@hikma.com

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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

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