FDA-Drug2024-12-25Class II

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

Hazard

Lack of Sterility Assurance

Sold states
Nationwide within the United States
Affected count
59275
Manufactured in
34176 Us Highway 19 N, Palm Harbor, FL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0153-2025

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