90%Confidence
0Views
FDASource
2026-04-06Date
Summary
Harbin Jixianglong's Semaglutide recall due to incomplete validation processes highlights significant regulatory risks in the compounding pharmacy supply chain, particularly for high-demand diabetes/weight loss medications. This may accelerate FDA scrutiny of foreign API manufacturers supplying the US compounding market.
Actionable: Immediately audit all compounding pharmacy suppliers for complete validation documentation and consider temporary sourcing alternatives for Semaglutide APIs.
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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