FDA recall D-0153-2025

Regenerative Processing Plant, LLC · Class II · drug

Product

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

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-0153-2025