85%Confidence
0Views
FDASource
2026-04-15Date
Summary
Appco Pharma's cGMP deviation for Prazosin capsules indicates systemic quality control failures affecting Biocon Pharma's supply chain. This recurring nitrosamine impurity issue across multiple strengths suggests manufacturing process vulnerabilities that could lead to product recalls and regulatory scrutiny.
Actionable: Monitor Biocon Pharma's stock for potential supply disruptions and increased regulatory oversight costs.
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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