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Domperidone products recalled after reclassification

Manufacturer Johnson & Johnson recalls two Motilium (domperidone) products after the MHRA reclassifies the drug as a prescription-only medicine.

Manufacturer Johnson & Johnson is recalling two Motilium (domperidone) products following the drug's reclassification as a prescription-only medicine.


Pharmacists should quarantine all remaining stock of the nausea and vomiting treatments until they were contacted by Johnson & Johnson with details of the returns process, the MHRA said yesterday (September 3).


Prescription-only domperidone products were not being recalled, the medicines watchdog said.


If pharmacists had not heard from the manufacturer by September 13 then they should contact Johnson & Johnson's pharmacy sales support department on 0808 238978, it said. For medical enquiries, pharmacies should contact the Johnson & Johnson professional information team on 01748 828800.


Domperidone was reclassified today (September 4) after a European Medicines Agency review found it was linked to a small increased risk of "potentially life-threatening effects on the heart", the MHRA said. The Commission on Human Medicines, an independent advisory body to the MHRA, had informed it that pharmacists would not be able to "accurately" assess cardiac risks without routine access to medical records, it added.


The affected products are:

Product Name

Pharmaceutical Form

Pack Size

Licence Number

Legal Status

Motilium 10

10mg tablets

1 x 10

PL 15513/0347

P

Motilium Instants

10mg orodispersible tablets

1 x 10

PL 15513/0350

P



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