PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 25, 2024 Initiated: December 10, 2024 #D-0153-2025

Product Description

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

Details

Units Affected
59275
Distribution
Nationwide within the United States
Location
Palm Harbor, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by Regenerative Processing Plant, LLC. Units affected: 59275.
Why was this product recalled?
Lack of Sterility Assurance
Which agency issued this recall?
This recall was issued by the FDA Drug on December 25, 2024. Severity: Moderate. Recall number: D-0153-2025.