Omnipod Insulin Management System Recall in Canada
Identify affected lots and implement recall procedures as per Health Canada guidelines.
2 SOPs may need review
Becton Dickinson UK Ltd is recalling ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators due to 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.
Regulatory Intelligence Lead
single-event
Identify and quarantine all impacted batches and return them to the supplier.
MHRA published a Class 2 recall for specific batches of ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators due to potential loss of sterility.
Use of non-sterile applicators for skin antisepsis prior to injection or catheter insertion could lead to serious infections.
Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.
Identify affected lots and implement recall procedures as per Health Canada guidelines.
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