Agency classClass IIOur severity:High FDA (Drugs)·D-0379-2024·Announced 2024-03-20

TRP Eye Strain Relief Eye Drops Recalled Due to Lack of Sterility Assurance

Optikem International recalls TRP Eye Strain Relief eye drops nationwide due to lack of assurance of sterility. Affected units are 10 mL bottles with Lot E206.

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: This is an FDA Class II recall of sterile eye drops due to lack of assurance of sterility, representing a risk-of-harm to users. No illnesses or injuries have been reported in the source material, which limits the severity to High rather than Severe.

Plain-English summary

Optikem International, Inc. is recalling TRP Eye Strain Relief sterile eye drops (10 mL bottles, 0.33 FL OZ) distributed nationwide in the USA. The affected product is identified by NDC # 17312-172-15 and Lot # E206 with an expiration date of 09-21-2025. A total of 10,536 bottles are affected.

The product is being recalled due to lack of assurance of sterility. Sterile eye drops must be manufactured under strict controls to ensure they are free of contamination. The manufacturer has determined that the manufacturing process did not provide adequate assurance that sterility standards were met.

The affected product was distributed nationwide in the USA. Any person who has purchased this product should stop using it immediately.

Consumers who have obtained this product should consult with their healthcare provider regarding safe alternatives. Healthcare providers and consumers may report adverse events or side effects to the FDA.

The recalled product

Product: TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.
Manufacturer: Optikem International, Inc.
Category: Drug — Ophthalmic / Eye Drops
Hazard: lack-of-sterility
Affected units: 10,536

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 (2)

Lot #: E206
Exp: 09-21-2025

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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