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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 02-Jul-2020 10:29:47

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
  • Primary Care Networks

Action category: Class 2: Action within 48 hours

Title: CLASS 2 DRUG ALERT, ACTION WITHIN 48 HOURS, PATIENT LEVEL RECALL, BCM SPECIALS LIMITED, MEPACRINE HYDROCHLORIDE 100MG TABLETS (UNLICENSED)

Broadcast content:
BCM Specials Limited has informed us that a number of foreign body particulates including glass and rubber have been found in one of the containers of the Active Pharmaceutical Ingredient (API) used in the manufacture of Mepacrine Hydrochloride 100mg tablets. No foreign body particulates were identified during the manufacturing process, routine associated batch analysis or investigative analysis performed to date, however, because of the use of API from the affected container in the manufacture of batch 85641 the decision to recall all available stock from this batch has been made as a precautionary measure.

Advice for healthcare professionals:
  • Contact patients who have been supplied Mepacrine Hydrochloride 100mg Tablets from the affected batch 85641 and ask them to stop using tablets from this batch as soon as possible and return any unused medicine to their pharmacy. 
  • Stop supplying the above products immediately and remove from the shelves within your store. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
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 and NHS Improvement Regional Offices: please cascade this alert to Community Pharmacy contractors.
GP Practices: Please note this alert is for Dispensing GP Practices only.


Alert reference: EL (20)A/27

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency