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Agenzia Italiana del Farmaco
Direct communication with healthcare professionals on NeoRecormon (epoetin beta) - Direct communication with healthcare professionals on NeoRecormon (epoetin beta)
Direct communication with healthcare professionals on NeoRecormon (epoetin beta)
NeoRecormon (epoetin beta): Risk of medication error - potential missing labels on NeoRecormon pre-filled syringes in single packs.
Summary:
- Missing labels were reported for five individual NeoRecormon pre-filled syringes (PFS) packaged in single-pack folding boxes distributed in France. Other single-pack batches of NeoRecormon PFS produced at the same time were also shipped to Italy, Poland, Romania and Slovenia. Only NeoRecormon batches manufactured before 28 March 2022 were potentially impacted by this defect. A list of the potentially impacted NeoRecormon batches can be found in the Annex.
- NeoRecormon PFS without a label SHOULD NOT be administered to patients, and the defect should be reported. In addition, contact Roche for further instructions.
- Healthcare professionals SHOULD CHECK NeoRecormon PFS within single packs prior to dispensing to ensure no unlabelled PFS are dispensed to the patients.
Published on: 13 October 2022
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