93%Confidence
0Views
FDASource
2026-04-15Date
Summary
Third Appco Pharma cGMP deviation for Prazosin 5mg capsules confirms systemic manufacturing quality issues across all strengths. This pattern increases the likelihood of FDA enforcement actions against both Appco and Biocon Pharma.
Actionable: Consider divesting from Biocon Pharma until they demonstrate resolution of these manufacturing quality issues.
AI Confidence: 93%
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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