FDA recall D-0152-2025

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2024-12-10

Report date

2024-12-25

Termination date

2025-06-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Palm Harbor, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0152-2025