90%Confidence
0Views
FDASource
2026-03-18Date
Summary
Harbin Jixianglong's semaglutide recall due to incomplete validation processes reveals significant quality system failures in the compounding supply chain for weight loss drugs. This creates regulatory risks for compounding pharmacies using Chinese-sourced active pharmaceutical ingredients and may accelerate FDA enforcement in the booming GLP-1 market.
Actionable: Immediately audit all compounding ingredients sourced from Chinese manufacturers and verify validation documentation before use.
AI Confidence: 90%
Data Points
firmHarbin Jixianglong Biotech Co., Ltd.
classificationClass II
statusOngoing
distributionNationwide within the United States
productSemaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-1
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