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The agency flagged three adverse events in its FAERS database tied to compounded injectable BPC-157, including a case in which a patient developed diffuse hyperpigmentation and gingival darkening after using a blended BPC-157/TB-500 product labeled "research purposes only." The safety concern most specific to BPC-157 is its mechanism of action

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Alpha-lipoic acid and N-acetylcysteine protects intensive swimming exercise-mediated germ-cell depletion, pro-oxidant generation, and alteration of steroidogenesis in rat testis