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| The United Kingdom: Class 3 Medicines Recall: Hikma Farmacêutica Portugal S.A., Gemcitabine 1g/26.3ml & 2g/52.6ml Solution For Infusion Vial (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Hikma Farmacêutica Portugal S.A. has informed the MHRA of a potential issue impacting the following products:
- Gemcitabine 1g/26.3ml Solution For Infusion Vial (batch number: CB0013)
- Gemcitabine 2g/52.6ml Solution For Infusion Vial (batch number: CB0014)
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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-3-medicines-recall-hikma-farmaceutica-portugal-s-dot-a-gemcitabine-1g-slash-26-dot-3ml-and-2g-slash-52-dot-6ml-solution-for-infusion-vial-el-23-a-slash-16
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, May 11, 2023
Issued at HKT 15:00
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