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Originator: MHRA Drug Alerts

 
From: Himal Makwana

Issue date: 30-Jun-2020 10:29:23

Action by recipients:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director

Information to recipients:
  • 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
  • GP Practices
  • DHSC Supply Disruption - Medicines
  • Primary Care Networks

Action category: Class 4: For information

Title: CLASS 4 DRUG ALERT, FOR INFORMATION, TENOLOL LIMITED (MA HOLDER) / DRUGSRUS LTD (DISTRIBUTOR), DEPO-PROVERA 150MG/ML INJECTION

Broadcast content:

Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder) have informed us of a typographical error for the active ingredient stated on the label on the vial. The active ingredient should be “medroxyprogesterone acetate” (a long acting contraceptive) however, it is stated as “methylpredinisolone acetate” (a corticosteroid) in error. The batches are not being recalled, as there are no concerns with the quality, safety and efficacy of the product. Existing stock at Drugsrus Ltd has been quarantined and no new stock will be released with the affected issue.

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 Offices: Please cascade this alert to any Community Pharmacy and Dispensing GP Practices yet to be registered with CAS.
GP Practices: Please note this alert is for Dispensing GP Practices only.


Alert reference: EL (20)A/26

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency