90%Confidence
0Views
FDASource
2026-04-19Date
Summary
Third Appco Pharma cGMP deviation for Prazosin 5mg capsules confirms widespread nitrosamine contamination across their entire Prazosin product line. This systematic failure suggests fundamental manufacturing process issues requiring significant remediation.
Actionable: Consider discontinuing sourcing from Appco Pharma until comprehensive quality system improvements are verified.
AI Confidence: 90%
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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