Requests that the FDA take action to address the imminent public health risk posed by the presence of high levels of immunogenic impurities in generic Indomethacin Suppositories, USP 50 mg, marketed by Hikma Pharmaceutical USA Inc. under ANDA 215899 and Amneal Pharmaceuticals LLC under ANDA 215399
🏛 Food and Drug Administration (FDA)FDA-2025-P-6089
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