REGULATORY INTELLIGENCE·Recall
Somerset Therapeutics' Brimonidine Tartrate Recall Highlights Ophthalmic Product Stability Risks
Somerset Therapeutics, LLC initiated a Class III recall of 48,852 bottles of Brimonidine Tartrate Ophthalmic Solution 0.2% due to label leaching impacting product stability. This event, now terminated, underscores critical packaging material compatibility challenges and the imperative for robust quality control in global pharmaceutical supply chains, particularly for generic ophthalmic drugs manufactured in India for the US market.
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