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uk updates on medical device regulation and quality.

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84 articles in UK
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Critical Recall Alert: Prednisolone 5mg Soluble Tablets by Activase Pharmaceuticals

Activase Pharmaceuticals Limited has issued a Class 3 medicines recall for two specific batches of Prednisolone 5mg Soluble Tablets as…

Europe

Urgent Recall: Hameln Pharma Ltd Issues Safety Notice for Clarithromycin 500mg Infusion Powder

Hameln Pharma Ltd has issued a Class 2 Medicines recall for specific batches of Clarithromycin 500 mg powder for concentrate…

Europe

Critical Updates: Field Safety Notices Issued from 1 to 5 December 2025

Clinical, quality, and regulatory teams should take note of the latest Field Safety Notices issued during the first week of…

Europe

Safety Notice: Flamingo Pharma UK Updates Required in Amitriptyline Hydrochloride PILs

Flamingo Pharma UK Ltd has issued a Class 4 Medicines Defect Notification for Amitriptyline Hydrochloride tablets. The Patient Information Leaflets…

Europe

Medicine Safety Alert: Baclofen 10mg Tablets Missing Correct Patient Safety Information

A safety advisory has been issued for Baclofen 10mg tablets, manufactured by Special Concept Development UK Limited. Regulatory authorities have…

Europe

Regulatory Update: MHRA Highlights November 2025’s Key Safety Insights for Medicines and Devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued its latest safety roundup for November 2025, aimed at providing…

Europe

Critical Updates: Field Safety Notices Issued for Medical Devices (Nov 17–21, 2025)

New updates on medical device safety concern all clinical, quality, and regulatory professionals. Between November 17 and November 21, 2025,…

Europe

Important Safety Notice: Updated Safety Information Missing from Moclobemide 150mg Tablets Packaging

On November 25, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a Class 4 Medicines Defect Notification regarding…

Europe

Critical Updates: Field Safety Notices Issued from 10–14 November 2025

Between 10 and 14 November 2025, significant Field Safety Notices (FSNs) were announced, carrying potential implications for stakeholders across clinical,…

Europe

Precautionary Recall of Fingolimod SUN 0.5mg by Sun Pharma: Capsule Breakage Risk Emerges

Sun Pharma UK Limited has issued a precautionary recall for one batch of Fingolimod SUN 0.5 mg hard capsules. This…

Europe

Urgent Medicines Recall: Atorvastatin 20mg & 80mg Tablets from Sun Pharma Due to Stability Concerns

Sun Pharma UK Limited has issued a precautionary recall of specific batches of their Atorvastatin 20mg and 80mg film-coated tablets.…

Europe

Medicine Recall: Zambon SpA Issues Precautionary Withdrawal of Emylif 50mg Film Over Stability Concerns

Zambon SpA has issued a recall of its Emylif 50mg orodispersible film as a precautionary measure following stability testing concerns.…

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