BUPRENORPHINE HYDROCHLORIDE

ENDO USA Recalls Buprenorphine HCl Injection Due to Particulate Matter: Supply Chain & Regulatory Implications

ENDO USA, Inc. initiated a Class II recall of 34,293 vials of Buprenorphine Hydrochloride Injection due to particulate matter (Buprenorphine free base). This nationwide event, involving manufacturer Par Health USA, LLC, signals heightened FDA scrutiny on sterile injectables. Procurement and regulatory teams must reassess supplier quality and risk mitigation strategies for critical medications like Buprenorphine HCl.