85%Confidence
0Views
FDASource
2026-04-14Date
Summary
Appco Pharma's cGMP deviation for Prazosin capsules due to nitrosamine impurities signals potential supply chain disruptions for Biocon Pharma. This recurring issue across multiple strengths indicates systemic manufacturing problems that could lead to product recalls and regulatory scrutiny.
Actionable: Monitor Biocon Pharma's supply chain for potential shortages and consider alternative suppliers for Prazosin Hydrochloride.
AI Confidence: 85%
Data Points
firmAppco Pharma LLC
classificationClass II
statusOngoing
distributionU.S.A. Nationwide
productPrazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma
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