Other

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.

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.

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.

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

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

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

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

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

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

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.

Ongoing investigations into unlawful vaping products are expected to result in further enforcement actions, including additional seizures and potential penalties for non-compliance with the Therapeutic Goods Act.

Regulatory intelligence workflows should address this enforcement action as part of ongoing compliance monitoring regarding the sale and promotion of unapproved therapeutic goods.