REGULATORY INTELLIGENCE·Recall
Sun Pharma Recalls Technetium Tc 99m Mertiatide Kits Over Dissolution Failure, Highlighting Systemic Quality Risks
Sun Pharmaceutical Industries Inc. has initiated a Class II recall of 1,870 kits of Technetium Tc 99m Mertiatide due to failed dissolution specifications, specifically an out-of-specification observation for sulphate in Sodium Tartrate Dihydrate. This event underscores persistent quality control challenges for Sun Pharma, demanding immediate supply chain risk assessment and diversification strategies from procurement directors and regulatory affairs heads.
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