92%Confidence
0Views
FDASource
2026-04-18Date
Summary
Third Appco Pharma cGMP deviation for Prazosin 5mg capsules confirms persistent nitrosamine contamination across their entire Prazosin product line. This indicates systemic manufacturing process failures requiring comprehensive remediation.
Actionable: Develop contingency plans for Prazosin supply chain disruptions and evaluate competitor products for potential substitution.
AI Confidence: 92%
Data Points
firmAppco Pharma LLC
classificationClass II
statusOngoing
distributionU.S.A. Nationwide
productPrazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma
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