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
The MHRA dismantled a major illicit manufacturing and distribution operation for unlicensed weight loss medicines, resulting in two arrests and a significant seizure of products in Northamptonshire.
Review adverse event reports for potential links to counterfeit weight loss medicines; check product supply chain for unlicensed sources.
Regulatory Intelligence Lead
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Heightened awareness of potential adverse event reports related to counterfeit or unlicensed weight loss treatments.
MHRA conducted its largest ever seizure of unlicensed weight loss medicines and arrested two individuals.
Illicit weight loss medicines pose serious health risks; this action highlights ongoing threat of counterfeit/unlicensed products entering the supply chain.
Review adverse event reports for potential links to counterfeit weight loss medicines; check product supply chain for unlicensed sources.
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
Identify affected lots and implement recall procedures as per Health Canada guidelines.
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