90%Confidence
0Views
FDASource
2026-04-19Date
Summary
Another Appco Pharma cGMP deviation for Prazosin 2mg capsules confirms a systemic manufacturing problem affecting multiple product strengths. This pattern increases regulatory risk for both Appco and Biocon Pharma, potentially affecting their entire product line.
Actionable: Evaluate exposure to 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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