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FDA Warning Letters

FDA Warning Letters

by Claire Dugdale | Aug 19, 2025 | Blog, MHRA

The MHRA has reviewed its current approach to contacting UK Licence Holders who may be implicated by USFDA Warning Letters

FSN for Zoll Powerheart G5 AEDs

FSN for Zoll Powerheart G5 AEDs

by Claire Dugdale | Jun 16, 2025 | Blog, MHRA

FSN (Field Safety Notice) for Zoll Powerheart G5 AEDs was issued by Zoll earlier this year for G5 AEDs that may display Error Code (EC) 501.

Next Entries »

Recent Posts

  • Major Changes to MHRA Medical Device Registration Fees
  • Major Changes to MHRA Medical Device Registration Fees
  • Online Booking Now Available!

Upcoming Courses

  • RP Forum – tbc on 3 February 2026 10:00 am
  • Export Online Training on 4 February 2026 10:00 am
  • Licence Holder Training on 5 February 2026 10:00 am
  • Superintendent Pharmacist training (Online) on 9 February 2026
  • GDP Audit Online Training on 11 February 2026 10:00 am

MHRA Alerts & Recalls

National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Quetiapine Oral Suspension (unlicensed medicine), manufactured by Eaststone Limited due to a potential for overdosing, NatPSA/2026/002/MHRA
29 January 2026
Class 4 Medicines Defect Notification: Viatris Products Ltd, Arixtra solution for injection, pre-filled syringes, EL(26)A/04
28 January 2026
Field Safety Notices: 19 to 23 January 2026
27 January 2026
MHRA Safety Roundup: January 2026
27 January 2026

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Hampshire
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