List of Field Safety Notices from 29 September to 3 October 2025.
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Class 2 Medicines Recall: Inhixa 12,000IU (120mg)/0.8mL solution for injection, Maxearn Limited, EL(25)A/27
Maxearn Limited have informed the MHRA that the carton used to package two imported batches of Inhixa have been released to the market with a typographical error on one side of the carton.
MHRA Safety Roundup: July 2025
Summary of the latest safety advice for medicines and medical device users
Guidance: AI Airlock Simulation Workshops
Key insights of three simulation workshops from the AI Airlock pilot testing programme. Please note that these documents are not formal guidance.
Transparency data: Medicines and Healthcare products Regulatory Agency GPC spending over £500: 2024-25
MHRA transactions over £500 made using the government procurement card (GPC).
Consultation on the International Council for Harmonisation (ICH) E21 Guideline on the Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials
The MHRA is consulting with UK stakeholders to gather feedback and comments on a new international guideline for the appropriate inclusion and/or retention of pregnant and/or breast-feeding individuals in clinical trials of medicines.
Field Safety Notices: 24 to 28 November 2025
List of Field Safety Notices from 24 to 28 November 2025.
