REGULATORY INTELLIGENCE·Recall
FDA Class I Recall: Aruba Aloe Balm's Lidocaine Gel Contaminated with Methanol, Impacting US Supply
Aruba Aloe Balm N.V. has initiated a Class I recall for 9,625 bottles of its Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, distributed nationwide in the USA. The recall, D-0459-2024, stems from chemical contamination: the product was manufactured with ethanol API containing methanol. This poses significant health risks, necessitating immediate action from procurement and regulatory teams to assess supply chain integrity.
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