Agency classClass IIOur severity:High FDA (Drugs)·D-0383-2024·Announced 2024-03-20

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units: 106,704

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.

Part of a larger recall action

This product is one of 10 recalled by Optikem International, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Same manufacturer · Optikem International, Inc.

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