REGULATORY INTELLIGENCE·Recall
FDA Class I Recall: SG24 LLC's SkinGuard 24 Hand Sanitizer Deemed Unapproved Drug Due to Methanol Content
SG24 LLC faced a Class I FDA recall for its SkinGuard 24 All-Day Hand Sanitizer, distributed nationwide from Bolingbroke, GA. The product, containing 0.56% methanol, was deemed an unapproved new drug, lacking required NDA/ANDA clearance. This event underscores critical regulatory compliance risks for chemical and life sciences firms, highlighting the imperative for rigorous ingredient verification and market authorization before product launch to avoid significant market disruptions and reputational damage.
90-Day Activity