REGULATORY INTELLIGENCE·Recall
Lupin Pharmaceuticals Recalls Bimatoprost Ophthalmic Solution Over Impurity Failures, Highlighting Supply Chain Risks
Lupin Pharmaceuticals Inc. initiated a Class III recall of 2,130 bottles of Bimatoprost Ophthalmic Solution, 0.03%, due to out-of-specification impurity levels from its Pithampur, India facility. This event underscores critical quality control vulnerabilities for procurement and regulatory teams, necessitating enhanced supplier due diligence and robust incoming material inspection protocols to mitigate supply chain disruption.
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