90%Confidence
0Views
FDASource
2026-04-18Date
Summary
Another Appco Pharma cGMP deviation for Prazosin 2mg capsules confirms systemic quality control problems with nitrosamine impurities. This pattern suggests broader manufacturing issues that could impact multiple products from this facility.
Actionable: Consider diversifying away from Appco Pharma-sourced products until quality issues are resolved.
AI Confidence: 90%
Data Points
firmAppco Pharma LLC
classificationClass II
statusOngoing
distributionU.S.A. Nationwide
productPrazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma
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