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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 15-Dec-2020 12:59:03

This alert has been issued to:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director

  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Foundation Trusts (England) - Chief Executive
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • GP - Locum
  • NHS 111 and Out of hours providers
  • Dispensing GP Practices
  • DHSC Supply Disruption - Medicines
  • Community Pharmacy
  • Primary Care Networks

Action category: Class 4: For information

Title: CLASS 4 DRUG ALERT, FOR INFORMATION, CO-CARELDOPA 25MG/100MG TABLETS, PL 20242/0028, FAIRMED HEALTHCARE GMBH

Broadcast content:
Fairmed Healthcare GmbH has informed us of a discrepancy on the product packaging for the specific batches. The discrepancy relates to the incorrect spelling of one of the active pharmaceutical ingredients printed on one side (end flap) of the packs in error. The incorrect end flap states that the active pharmaceutical ingredient is ‘carbiopa’ instead of ‘carbidopa’, (see Annex 1 in the attached PDF). The other product details on the pack including the name, strength and pharmaceutical form of the medicine are correct on all other sides of the carton. 

Advice for healthcare professionals
Healthcare professionals are advised to exercise caution when dispensing the product. There is no risk to product quality as a result of this issue, therefore the associated batches are not being recalled at this time.

Full details of the drug alert are in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-device-alerts



Additional information: NHS England and NHS Improvement Regional Offices: please cascade this alert to Community Pharmacies.
GP Practices: please note this alert is for Dispensing GP Practices only.


Alert reference: EL (20)A/59

Attachments:
Cascade to:
  • #COMMUNITYPHARMACISTS#
  • #DISPENSING GP#
  • #HospitalPharmacy#


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency