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🏥 FDA: Harbin Jixianglong Biotech Co., Ltd. — Class II

healthcareactionableSource: FDA
88%Confidence
0Views
FDASource
2026-04-01Date

Summary

Harbin Jixianglong's Semaglutide recall due to incomplete validation processes reveals significant quality system failures in a high-demand diabetes/weight loss drug component. This highlights risks in the compounding pharmacy supply chain and could affect semaglutide availability.

Actionable: Immediately audit all compounding pharmacy suppliers for proper validation documentation and consider alternative API sources for semaglutide formulations.

AI Confidence: 88%

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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