REGULATORY INTELLIGENCE·Recall
FDA Class I Recall: HANDELNINE GLOBAL LLC's Rheumacare Capsules Contaminated with Lead Due to CGMP Deviations
HANDELNINE GLOBAL LLC has initiated a Class I recall for Rheumacare capsules due to lead contamination, stemming from CGMP deviations at its Indian manufacturer, Virgo UAP Pharma Pvt. Ltd. This event underscores critical supply chain vulnerabilities and the imperative for rigorous quality oversight, particularly for imported pharmaceutical products, demanding immediate attention from procurement and regulatory teams to mitigate severe health risks and business disruption.
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