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MAHs and sponsors must register for an EMA account and appropriate role to submit via the IRIS platform, as this is a new requirement for all IRIS submissions.

Organizations must establish an active EMA user account, ensure they have a valid EMA customer account number, and complete the SPOR/OMS registration process within five to ten working days if not previously registered.

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

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

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

Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.

Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form to GE HealthCare.

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.

Immediately stop using the recalled stools, store away from children, and contact Wan Yi (866-677-3889 / customerservice-ca@cosyland.com) to request free repair parts (protective nets, stabilizing feet, instructions).

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

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

Immediately stop use; visit Wyze Labs website for refund process. Report incidents to Health Canada.

Stop using affected batches; return to place of purchase for full refund.

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

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

Identify and quarantine affected ARTIS Icono systems in inventory; contact manufacturer for update guidance.

Healthcare facilities should implement manufacturer's corrective actions to ensure safe operation.

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

Review the specific labeling changes required by the FDA order and update internal safety documents and signal evaluation for ADZYNMA accordingly.

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