91%Confidence
0Views
FDASource
2026-04-14Date
Summary
Third Appco Pharma nitrosamine deviation for Prazosin 5mg capsules confirms systemic manufacturing quality issues affecting their entire Prazosin product line. This pattern increases regulatory risk and suggests potential compliance actions against the manufacturing facility.
Actionable: Develop alternative sourcing strategies for all products manufactured by Appco Pharma and increase quality oversight of their supply chain.
AI Confidence: 91%
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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