Drug & medication recalls Moderate risk

Regenerative Processing Plant, LLC recalls LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactu…

Recall date
December 10, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0152-2025
FDA classification
Class II
Brand / firm
Regenerative Processing Plant, LLC
Sold / distributed
Nationwide within the United States

Why it was recalled

Lack of Sterility Assurance

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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