MHRA Class 2 Recall: ChloraPrep 2% applicators (potential sterility breach)
Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.
2 SOPs may need review
Health Canada posted a recall for Omnipod Insulin Management System due to product performance issues.
Identify affected lots and implement recall procedures as per Health Canada guidelines.
Regulatory Intelligence Lead
action required within 24 hours
Health Canada announced a recall for Omnipod Insulin Management System due to product performance issues.
Product performance issues may lead to insulin delivery errors, posing serious health risks to users.
Identify affected lots and implement recall procedures as per Health Canada guidelines.
Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.
2 SOPs may need review
Review adverse event reports for potential links to counterfeit weight loss medicines; check product supply chain for unlicensed sources.
2 SOPs may need review
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.
2 SOPs may need review
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.
2 SOPs may need review