FDA Drugs recall ·
LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles… recall
- Recall number
- D-0152-2025
- Date
- (initiated December 10, 2024)
- Company / brand
- Regenerative Processing Plant, LLC
34176 Us Highway 19 N, Palm Harbor, FL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 170812 bottles
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Lack of Sterility Assurance
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: P121322A, P121322B, Exp. Date 12/13/2024; P121422A, Exp. Date 12/14/2024; P121922A, P121922B, Exp. Date 12/19/2024; P122022A, Exp. Date 12/20/2024; P122122A, P122122B, Exp. Date 12/21/2024; P122622A, P122622B, Exp. Date 12/26/2024; P122722A, P122722B, Exp. Date 12/27/2024; P122822A, P122822B, Exp. Date 12/28/2024. P010223A, Exp. Date 1/2/2025; P010323LV1, Exp. Date 1/3/2025; P010523A, P010523B, Exp. Date 1/5/2025; P010923A, Exp. Date 1/9/2025; P011023LV2, Exp. Date 1/10/2025, P011223A, P011223B, Exp. Date 1/12/2025; P011623A; Exp. Date 1/16/2025, P011723LV3, Exp. Date 1/17/2025; P011923A, P011923B, Exp. Date 1/19/2025; P012323A, P012323B, Exp. Date 1/23/2025; P012523A, Exp. Date 1/25/2025; P013123A, Exp. Date 1/31/2025; P020223A, Exp. Date 2/2/2025; P020623A, Exp. Date 2/6/2025,P020823A, Exp. Date 2/8/2025, P020923A, Exp. Date 2/9/2025, P021323A, Exp. Date 2/13/2025; P021523A, P021523B, Exp. Date 2/15/2025, P021623A, Exp. Date 2/16/2025, P022023A, Exp. Date 2/20/2025, P022123A, Exp. Date 2/21/2025, P022323A, Exp. Date 2/23/2025, P022723A, Exp. Date 2/27/2025, P030123A, Exp. Date 3/1/2025, P030223A, Exp. Date 3/2/2025, P030623A, Exp. Date 3/6/2025; P030723A, Exp. Date 3/7/2025; P030823A, Exp. Date 3/8/2025; P030923A Exp. Date 3/9/2025, P031423A, Exp. Date 3/14/2025, P032023A, Exp. Date 3/20/2025, P032123A, Exp. Date 3/21/2025; P032223A, Exp. Date 3/22/2025; P032723A, Exp. Date 3/27/2025; P040423A, Exp. Date 4/4/2025; P040523A, Exp. Date 4/5/2025; P040623A, Exp. Date 4/6
Distribution
Nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0152-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.