REGULATORY INTELLIGENCE·Recall
AVKARE Inc. Dutasteride Recall: Impurity Failures Highlight Critical Supply Chain Vulnerabilities
AVKARE Inc. initiated a Class II recall of 3,989 cartons of Dutasteride Capsules, 0.5 mg, due to high out-of-specification impurity levels. This nationwide U.S. distribution event, terminated in 2021, underscores the critical need for robust quality control and diversified sourcing strategies for procurement directors and supply chain VPs to mitigate disruption and ensure patient safety.
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