REGULATORY INTELLIGENCE·Recall
FDA Mandates Class II Recall for BRS Analytical Services' Ophthalmic Gel Over cGMP Deviations and Sterility Concerns
BRS Analytical Services, LLC initiated a Class II recall for Carboxymethylcellulose Sodium Ophthalmic Gel 1% due to critical cGMP deviations and sterility assurance failures. This impacts 1,610 cases distributed nationwide, posing significant supply chain and regulatory risks for procurement and regulatory affairs leaders. Immediate action is required to assess supplier compliance and mitigate disruption.
90-Day Activity
BRS Analytical Services, LLCCarboxymethylcellulose Sodium
CMCatherine Morrow· Senior Regulatory Intelligence Analyst2025-05-14