REGULATORY INTELLIGENCE·Recall
Sun Pharma's Amphotericin B Recall: Assay Failure Impacts US Supply Chain
Sun Pharmaceutical Industries, Inc. has initiated a Class II recall of 11,016 vials of Amphotericin B Liposome for Injection due to out-of-specification assay results. This voluntary action, originating from its Halol, India facility, impacts nationwide distribution in the United States, necessitating immediate review by procurement and regulatory teams to mitigate potential supply disruptions for this critical antifungal medication.
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