FDA-Drug2024-12-25Class II
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
Regenerative Processing Plant, LLC
Hazard
Lack of Sterility Assurance
Sold states
Nationwide within the United States
Affected count
170812 bottles
Manufactured in
34176 Us Highway 19 N, Palm Harbor, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0152-2025Don't want to check this manually?
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