REGULATORY INTELLIGENCE·Recall
Amneal Pharmaceuticals Initiates Class II Recall of Phenoxybenzamine Hydrochloride Capsules Due to Unknown Impurity
Amneal Pharmaceuticals of New York, LLC, has executed a Class II recall for Phenoxybenzamine Hydrochloride Capsules, USP 10mg, due to an out-of-specification unknown impurity. This nationwide recall, impacting 858 bottles, necessitates immediate supply chain and quality assurance reviews for procurement directors and regulatory affairs heads, highlighting critical supplier quality control risks for this essential molecule.
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