Broncochem Cold & Flu Syrup Kids

Global Corporation has initiated a Class II recall of 9,831 bottles of Broncochem Cold & Flu Syrup Kids due to stability testing failures for Phenylephrine HCl and/or Chlorpheniramine Maleate. This voluntary action, impacting nationwide U.S. distribution, underscores critical risks in contract manufacturing oversight and API quality control. Procurement and regulatory teams must reassess supplier qualification and post-market surveillance protocols to mitigate similar supply chain disruptions.

Global Corporation faces significant FDA regulatory findings concerning Broncochem Cold & Tea, stemming from critical stability testing failures for Phenylephrine HCl and/or Chlorpheniramine Maleate. This Class II recall, impacting 2,345 boxes nationwide, underscores severe quality control vulnerabilities. Procurement and regulatory teams must assess their supply chain resilience for these common APIs and prepare for heightened FDA oversight and potential further enforcement actions.