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publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 8, 2026

Field Safety Notice: Bolton Medical RelayPro Thoracic Stent-Graft System (NBS)

Urgency: High

Verify inventory of affected RelayPro Thoracic Stent-Graft System lots (model 28-N4-XX-XXX-XXS) and implement actions per the FSN document.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Field Safety Notice (FSN)
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publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 8, 2026

Class 4 Defect Notification: Cadila Mirtazapine 30mg Tablets (EL(26)A/28)

Urgency: High

Check for affected batches of Mirtazapine 30mg Tablets as described in EL(26)A/28 and implement any necessary quarantining or recall steps.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Medicines Defect Notification (Class 4)
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publicTGA · Australia · Updated Jun 5, 2026

TGA Safety Alert: FluMist Indicated Age Range Errors

Urgency: High

Confirm child is 24 months or older before administering FluMist; review Product Information; verify patient age against indication.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Alert
Read impact briefarrow_forward
publicEuropean Medicines Agency (EMA) · European Union · Updated Jun 5, 2026

Ixchiq (Chikungunya vaccine (live)) - Safety measures following PRAC review

Urgency: High

Update product information and guidance for use in elderly populations for Ixchiq; ensure compliance with PRAC recommendations.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: PRAC recommendation
Read impact briefarrow_forward
publicEuropean Medicines Agency (EMA) · European Union · Updated Jun 5, 2026

EMA Updates Acceptable Intake Levels for Nitrosamine Impurities in Human Medicines

Urgency: High

Manufacturers must verify that their products meet the newly established acceptable intake levels for nitrosamines and implement necessary quality control measures to keep impurities within limits.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Regulatory Update
Read impact briefarrow_forward
publicFDA · USA · Updated Jun 5, 2026

GE HealthCare Infant Resuscitation System Air-Oxygen Blender Issue

Urgency: High

Identify and remove affected devices from use until corrected; if use is necessary, follow additional precautions provided in the GE HealthCare customer letter.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Early Alert
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publicHSA · Singapore · Updated Jun 4, 2026

Urgent Field Action Notification of Advanced Bionics HiRes Ultra / Ultra 3D

Urgency: High

Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Urgent Field Action
Read impact briefarrow_forward
publicTherapeutic Goods Administration (TGA) · Australia · Updated Jun 4, 2026

Pharmatech MK-677 Capsules: Undisclosed Anabolic Steroid Found

Urgency: High

Stop using and dispose of Pharmatech MK-677 capsules immediately; consult a healthcare professional if concerned.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Alert
Read impact briefarrow_forward
publicTGA · Australia · Updated Jun 4, 2026

Unapproved ibutamoren capsules (MK-677) found to contain undisclosed anabolic steroid

Urgency: High

Consumers must stop taking the product immediately and return remaining capsules to a pharmacy for safe disposal.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Alert
Read impact briefarrow_forward
publicHSA · Singapore · Updated Jun 4, 2026

HeartWare Ventricular Assist System Batteries - HSA Field Safety Notice

Urgency: High

Identify and quarantine affected HeartWare batteries; follow manufacturer's instructions for battery management and replacement; ensure patients and healthcare providers are informed.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Field Safety Notice
Read impact briefarrow_forward
publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated May 29, 2026

MHRA Largest Seizure of Unlicensed Weight Loss Medicines

Urgency: High

Review adverse event reports for potential links to counterfeit weight loss medicines; check product supply chain for unlicensed sources.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Enforcement Action / Public Safety Alert
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publicFDA · United States · Updated May 29, 2026

FDA Public Notification: Tawon Liar Contains Hidden Drug Ingredients

Urgency: High

Review product inventory for Tawon Liar; report any adverse events to FDA MedWatch; consider adding product to signal monitoring list; ensure labeling compliance checks for similar products.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Public Notification
Read impact briefarrow_forward
publicEMA · European Union · Updated Jun 5, 2026

Calcifediol PSUSA: Maintenance of Marketing Authorisation (PSUSA/00000491/202506)

Monitoring

Review the PSUSA documents for calcifediol and ensure alignment with any PRAC recommendations if applicable.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: PSUSA
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publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 4, 2026

Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe

Monitoring

Check stock for the affected batches of Ponlimsi (Denosumab) 60mg solution for injection and follow the instructions in the MHRA notice.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Medicines recall/notification
Read impact briefarrow_forward
publicEuropean Medicines Agency (EMA) · European Union · Updated May 29, 2026

EMA ETF recommends updating COVID-19 vaccines to target XFG variant for 2026/2027 campaign

Monitoring

Marketing authorisation holders should prepare to update their COVID-19 vaccines to target the XFG variant for the upcoming campaign; monitor for further regulatory guidance and prepare for potential strain change submissions.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Regulatory Recommendation / Public Health Communication
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Tag: other | PV Bulletin