90%Confidence
0Views
FDASource
2026-03-21Date
Summary
Harbin Jixianglong's Semaglutide recall for lacking process validation before distribution highlights significant regulatory compliance failures in the compounding pharmacy supply chain. This creates risks for compounded weight loss medications and may lead to increased FDA scrutiny of imported active pharmaceutical ingredients.
Actionable: Immediately audit all compounded medication suppliers for proper validation documentation and consider suspending use of unvalidated imported 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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