Recalls / Class II
Class IID-0153-2025
Product
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
- Brand name
- Regener-eyes
- Generic name
- Regener-eyes
- Active ingredient
- Glycerin
- Route
- Ophthalmic
- NDC
- 82305-003
- FDA application
- M018
- Affected lot / code info
- Lot #: P120522A, Exp. Date 12/5/2025, P120522B, Exp. Date 12/5/2024; P120822A, Exp. Date 12/8/2024; P1208228, Exp. Date 12/8/2024; P121222A, P1212228, Exp. Date 12/12/2024; P121922A, P121922B, Exp. Date 12/19/2024; P122222A, Exp. Date 12/22/2024; P122622A, P122622B, Exp. Date 12/26/2024; P010223A, Exp. Date 1/2/2025; P010423PV1, Exp. Date 1/4/2025; P010523A, P010523B, Exp. Date 1/5/2025; P010923A, Exp. Date 1/9/2025; P011123PV2, Exp. Date 1/11/2025; P011223A, P011223B, Exp. Date 1/12/2025; P011623A, Exp. Date 1/16/2025; P011823PV3, Exp. Date 1/18/2025; P011923A, P011923B, Exp. Date 1/19/2025; P012323A, P012323B, Exp. Date 1/23/2025; P012623A, Exp. Date 1/26/2025; P013023A, Exp. Date 1/30/2025; P020123A, Exp. Date 2/1 /2025; P020723A, Exp. Date 2/7/2025; P021423, Exp. Date 2/14/2025, P021623A, Exp. Date 2/16/2025; P022023A, Exp. Date 2/20/2025; P022223A, Exp. Date 2/22/2025; P022823A, Exp. Date 2/28/2025; P030123A, Exp. Date 3/1/2025; P050423A, Exp. Date 5/4/2025, P051823A, Exp. Date 5/18/2025, P052523A, Exp. Date 5/25/2025
Why it was recalled
Lack of Sterility Assurance
Recalling firm
- Firm
- Regenerative Processing Plant, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 34176 Us Highway 19 N, Palm Harbor, Florida 34684-2144
Distribution
- Quantity
- 59275
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-12-10
- FDA classified
- 2024-12-17
- Posted by FDA
- 2024-12-25
- Terminated
- 2025-06-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0153-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.