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Originator: MHRA Drug Alerts

From: Sze Mun Tan

Issue date: 15-Jul-2020 10:29:08

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, DR REDDY'S LABORATORIES (UK) LIMITED, NITROFURANTOIN 50MG TABLETS

Broadcast content:

Dr Reddy’s Laboratories (UK) Limited is recalling all unexpired stock of a specific batch of Nitrofurantoin 50mg Tablets from pharmacies and wholesalers as a precautionary measure due to out of specification results for dissolution during routine stability testing.

Advice for healthcare professionals:

Stop supplying the affected batch immediately. Quarantine all remaining stock and return these 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/28

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency