REGULATORY INTELLIGENCE·Warning Letter
FDA Class II Recall: Regenerative Processing Plant's REGENER-EYES Ophthalmic Solution Lacks Sterility Assurance
Regenerative Processing Plant, LLC has completed a Class II recall of 170,812 bottles of LITE Regener-Eyes Ophthalmic Solution due to a critical lack of sterility assurance. This event, initiated December 10, 2024, impacts nationwide U.S. distribution, necessitating immediate supply chain review for procurement directors. The termination on June 27, 2025, confirms the closure of this specific recall, yet highlights ongoing risks in ophthalmic product manufacturing.
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