Appco Pharma LLC — Manufacturing Site

Appco Pharma LLC has initiated a Class II recall for 88,008 bottles of Prazosin Hydrochloride Capsules due to N-nitroso-prazosin impurity C (NNP) exceeding acceptable limits. This firm-initiated action, stemming from cGMP deviations at their Piscataway, NJ facility, impacts U.S. nationwide distribution. This event underscores a concerning pattern of quality control issues for Appco Pharma, demanding immediate supply chain risk assessment.

Appco Pharma LLC has initiated a nationwide Class II recall of 58,896 bottles of Prazosin Hydrochloride Capsules, 2mg, due to N-nitroso-prazosin impurity C (NNP) exceeding acceptable limits. This cGMP deviation, impacting product manufactured for Biocon Pharma Inc., underscores Appco Pharma's recurring quality control challenges, necessitating immediate supply chain reassessment and diversification for procurement directors and regulatory affairs heads.

Appco Pharma LLC initiated a Class III recall for 1,380 bottles of Venlafaxine Extended-Release Tablets due to missing tablet identification. This event, following a 2020 Class II Ranitidine recall, highlights recurring quality control issues. Procurement and regulatory teams must assess supplier risk and explore alternative sources for Venlafaxine Hydrochloride to ensure supply chain resilience.