TRP Natural Eyes Dryness Relief Eye Drops Recalled for Lack of Sterility Assurance
Optikem International, Inc. is recalling TRP Natural Eyes Dryness Relief eye drops due to lack of assurance of sterility. The product was distributed nationwide in the USA.
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: This is an FDA Class II recall of a sterile ophthalmic product with no reported illnesses or injuries. As a risk-of-harm product where injury has not yet been reported, it meets the rubric criterion for Score 3.
Plain-English summary
Optikem International, Inc. is recalling TRP Natural Eyes Dryness Relief, Sterile Eye Drops (0.33 FL OZ / 10 mL) because the product does not have assurance of sterility. The affected product has NDC # 17312-178-15 and includes lots D101, D102, and D103.
Sterile eye drops must meet strict sterility standards to prevent contamination. A lack of assurance of sterility means the product may not meet required standards and could pose a risk of microbial contamination.
Approximately 47,832 bottles were distributed nationwide. Consumers who have this product should stop using it immediately and consult a healthcare provider if they have any questions or concerns.
The recalled product
- Product
- TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.
- Manufacturer
- Optikem International, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- sterility-failure
- contamination-risk
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 (6)
- Lot #: D101
- Exp: 07-01-2024
- D102
- Exp: 12-01-2024
- D103
- Ep: 04-13-2025
Distribution
Distributed nationwide across the United States.
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