REGULATORY INTELLIGENCE·Recall
FDA Terminates Sun Pharma's Nitrofurantoin Recall Amidst Recurring Dissolution Failures
SUN PHARMACEUTICAL INDUSTRIES INC faced an FDA Class II recall for Nitrofurantoin Capsules due to failed dissolution specifications. This event, now terminated, highlights recurring quality control challenges for the company, impacting supply chain stability for this essential antibiotic. Procurement and regulatory teams must assess current sourcing strategies and monitor Sun Pharma's broader compliance efforts.
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