Product: LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-01
Reason for recall: Lack of Sterility Assurance
Recall initiated: 20241210
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated