FDA's Dallas district office inspected Revive Rx LLC (Houston, TX) between January 27 and February 7, 2025 and issued a Form 483 citing sterile-failure observations — products exposed to sub-ISO 5 air and microbial contamination (mold and spore-forming bacteria) in production areas. The 483's product list includes Hexarelin 6 mg per Vial for Injection among the drugs the compounding pharmacy produced, alongside sermorelin and tesamorelin. The document is inspectional observations, not a final agency determination.
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