REGULATORY INTELLIGENCE·Recall
DermaRite Industries Recalls DermaFungal Cream Over CGMP Deviation and Contamination Risk
DermaRite Industries, LLC has initiated a nationwide Class II recall (D-0162-2026) for its DermaFungal Antifungal Cream containing 2% Miconazole Nitrate. The recall, impacting 1,480 packets, stems from a Current Good Manufacturing Practice (CGMP) deviation at its North Bergen, NJ facility, where other products were found contaminated. This event underscores critical supply chain vulnerabilities for procurement and regulatory teams sourcing topical antifungal agents, necessitating immediate risk assessment and potential diversification strategies to mitigate disruption.
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