TRP Natural Eyes Red Eye Relief eye drops recalled for sterility concerns
The FDA is recalling 106,704 bottles of TRP Natural Eyes Red Eye Relief eye drops due to lack of sterility assurance. Consumers should stop using the product and contact a healthcare provider if they experience eye irritation or infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of sterile eye drops with lack of assurance of sterility. No reported illnesses or injuries are documented in the source, but the product poses a clear risk of harm through potential microbial contamination leading to serious eye infections.
Plain-English summary
TRP Natural Eyes Red Eye Relief, a sterile ophthalmic eye drop product, is being recalled nationwide. The product is homeopathic eye drops in 0.33 FL OZ (10 mL) bottles, manufactured by Optikem International, Inc. for TRP Company, Inc.
The FDA determined that the manufacturer cannot assure the product's sterility. This poses a risk that the product may be contaminated. The recall affects 106,704 bottles distributed nationwide in the USA.
Affected lot numbers are R608 (expires 04-21-2024), R609 (expires 05-19-2024), R610 (expires 07-28-2024), R611 (expires 10-06-2024), R612 (expires 02-02-2025), R613 (expires 10-12-2025), and R614 (expires 11-02-2025). Consumers who have purchased this product should discontinue use immediately and consult a healthcare provider if they have experienced any eye irritation, redness, or signs of infection after using this product.
The recalled product
- Product
- TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.
- Manufacturer
- Optikem International, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- lack-of-sterility
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- Lot #: R608
- Exp:04-21-2024
- R609
- Exp: 05-19-2024
- R610
- Exp: 07-28-2024
- R611
- Exp: 10-6-2024
- R612
- Exp: 02-02-2025
- R613
- Exp: 10-12-2025
- R614
- Exp: 11-02-2025
Distribution
Distributed nationwide across the United States.
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