Central Alerting System
View Alert


Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 24-Feb-2020 15:11:52

This alert has been issued to:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director
  • Territorial CMOs in Northern Ireland, Scotland & Wales

  • 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
  • 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
  • GP Practices
  • Primary Care Networks

Action category: Class 4: For information

Title: CLASS 4 DRUG ALERT, FOR INFORMATION, CRESCENT PHARMA LTD AND FLAMINGO PHARMA (UK) LTD, IBUPROFEN 400MG TABLETS (VARIOUS LIVERIES) - UPDATE

Broadcast content:

*Please note this is an update to EL(20)A/10 to include updated batches that are affected for Crescent Pharma Ltd. There are two documents attached, one is the fully updated drug alert containing all impacted batches, including those identified when the drug alert was first issued. The second document contains the newly identified batches only.*

Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed us that the Patient Information Leaflet (PIL) within their packs for the above pharmacy (P) batches is incorrect. 
When dispensing or providing this product over the counter, please check the Marketing Authorisation Holder and the batch number; if any of the above batch numbers are being dispensed, ensure that patients are aware of the correct dosage instructions and maximum daily dose as stated on the carton labelling.

  •  Correct statement: The maximum daily dose should not be more than 3 [three] tablets (1200 mg).

Where possible, these packs should be considered to be dispensed against a prescription rather than sold over the counter to safeguard patients from taking a prescription only dose.

Full details of the drug alert are included 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 Regional Office: Please cascade this alert to Community Pharmacy and any Dispensing GP Practices not yet registered with CAS.
GP Practices: Please note this alert is only relevant for Dispensing GP Practices.


Alert reference: EL (20)A/10(U)

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency