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Batch 11 was an intermediate batch showing intermediate release over 24 hrs

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FDA nonclinical toxicology review (2023-2024) flagged DNA damage in pituitary cells and injection-site necrosis in animal studies, plus immunogenicity and impurity risks from compounded material, alongside GH/IGF-1-axis effects such as fluid retention, joint discomfort, flushing, and headache reported by users