Class 4 Medicines Defect Notification: Hikma Farmacêutica, Gemcitabine 2g/52.6ml Concentrate For Solution For Infusion, El(25)a/43
Hikma Farmacêutica is recalling batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion in the United Kingdom because the patient information leaflet included with the product is missing information about serious skin reactions as a potential side effect. The defect affects the printed information provided to patients, not the medicine itself.
- Recalling firm
- Hikma Farmacêutica
- Reason
- Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.
- Classification
- Class III
- Category
- drug recall
- Country
- United Kingdom
- Agency
- UK Medicines and Healthcare products Regulatory Agency
- Recall date
- 2025-09-04
- Status
- Ongoing
- Distribution
- United Kingdom
Official recall notice from UK Medicines and Healthcare products Regulatory Agency
Recall details on Nibble Recalls: https://trynibble.app/recalls/1c87bfe3-197a-43a0-b788-cb724175c6d0