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
Reported: December 25, 2024 Initiated: December 10, 2024 #D-0152-2025
Product Description
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
Reason for Recall
Lack of Sterility Assurance
Details
- Recalling Firm
- Regenerative Processing Plant, LLC
- Units Affected
- 170812 bottles
- Distribution
- Nationwide within the United States
- Location
- Palm Harbor, FL
Frequently Asked Questions
What product 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. Recalled by Regenerative Processing Plant, LLC. Units affected: 170812 bottles.
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-0152-2025.
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