Buprenorphine Hydrochloride

Teva Pharmaceuticals USA initiated a Class II recall for its Buprenorphine Transdermal System 5 mcg/hour due to a critical failure in stability specifications, specifically a below-spec buprenorphine release rate. This nationwide recall, impacting 32,543 cartons manufactured by 3M Drug Delivery Systems, underscores the imperative for robust quality control and supplier oversight in pharmaceutical supply chains to prevent market disruptions and regulatory scrutiny.

Matthew 7:25 Inc dba Thrive Pharmacy faced an FDA Class II recall for subpotent Buprenorphine Black Cherry 2 mg Troches, lot 191217A, distributed in Florida. This voluntary, firm-initiated action, terminated in June 2023, highlights critical quality control failures. Procurement and regulatory teams must enhance due diligence for compounded products to mitigate efficacy and safety risks.