Multi event Drug Recall Enforcement Report Class II voluntary initiated by Regenerative Processing Plant, LLC, originally initiated on 12-10-2024 for the 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 The product was recalled due to lack of sterility assurance. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0152-2025 | 12-10-2024 | 12-25-2024 | Class II | 170812 bottles | 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 | Lack of Sterility Assurance | Terminated |
| D-0153-2025 | 12-10-2024 | 12-25-2024 | Class II | 59275 | PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01 | Lack of Sterility Assurance | Terminated |
Recalled Products
