90%Confidence
0Views
FDASource
2026-04-14Date
Summary
Another Appco Pharma cGMP deviation for Prazosin 2mg capsules confirms pattern of nitrosamine contamination issues across their product line. This suggests broader manufacturing deficiencies that could impact multiple drug products from this facility.
Actionable: Assess exposure to all Appco Pharma manufactured products and develop contingency sourcing plans.
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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