85%Confidence
0Views
FDASource
2026-03-17Date
Summary
Harbin Jixianglong's Semaglutide recall due to missing validations creates significant risks for compounding pharmacies relying on this API, potentially affecting GLP-1 agonist supply during high demand. The Chinese manufacturer's compliance failures may accelerate regulatory scrutiny of offshore API suppliers.
Actionable: Audit all Semaglutide API sources and prioritize suppliers with complete validation documentation to ensure patient safety.
AI Confidence: 85%
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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