REGULATORY INTELLIGENCE·Warning Letter
FDA Class II Recall: BSO LLC's Testosterone Pellets Contaminated with Glass Particles
BSO LLC has initiated a nationwide Class II recall (D-0412-2025) for 2,762 vials of TESTOSTERONE PELLET 100 mg due to glass particle contamination. This event highlights critical quality control failures at the Lakewood, CO facility, posing significant patient safety risks and immediate supply chain disruptions for healthcare providers relying on this compounded drug. Decision-makers must assess supplier risks and ensure robust quality assurance.
90-Day Activity
BSO LLCEsokalli Testosterone Booster Oral Dissolving FilmHSN TESTOSTERONE PELLET 100 mg
MKMeera Krishnan· Senior Regulatory Intelligence Analyst2025-05-14