Agency classClass IIOur severity:High FDA (Drugs)·D-1165-2023·Announced 2023-09-27

TRP Natural Eyes Stye Relief sterile eye ointment recalled for lack of sterility assurance

FDA is recalling TRP Natural Eyes Stye Relief sterile eye ointment due to lack of assurance of sterility. The product was distributed to two accounts in Rhode Island and Colorado.

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 classified this as a Class II recall for lack of sterility assurance in an ophthalmic product. Since no illnesses or injuries have been reported and the hazard is theoretical, this qualifies as a risk-of-harm product without documented injury, scoring as High per the rubric criteria.

Plain-English summary

TRP Natural Eyes, Stye Relief is a homeopathic sterile eye ointment (0.14 oz / 4 grams) manufactured by AMMAN PHARMACEUTICAL INDUSTRIES in Jordan for TRP Company, Inc. (NDC 17312-014-13). A total of 180,315 units are subject to this recall.

The FDA initiated this recall due to lack of assurance of sterility. Sterile products must meet established standards for sterilization to ensure safety.

The affected lots are: 182002 (EXP 11/24), 182003 (EXP 11/24), 182004 (EXP 12/24), 182005 (EXP 02/25), 182006 (EXP 02/25), 182007 (EXP 02/25), 182008 (EXP 02/25), 182009 (EXP 02/25), 182010 (EXP 03/25), and 182011 (EXP 03/25). The product was distributed to two direct accounts in Rhode Island and Colorado.

Individuals who possess this product should stop using it and speak with a healthcare provider if they have concerns about their health.

The recalled product

Product: TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13.
Manufacturer: AMMAN PHARMACEUTICAL INDUSTRIES
Category: Drug — Ophthalmic
Hazard: lack-of-sterility
Affected units: 180,315

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 (9)

Lot:182002 EXP: 11/24
Lot:182003 EXP: 11/24
Lot:182004 EXP: 12/24
Lot:182005 EXP:02/25
Lot:182006 EXP:02/25
Lot:182007EXP:02/25
Lot:182008 EXP:02/25
Lot:182009 EXP:02/25
Lot:182010 EXP:03/25: Lot:182011 EXP:03/25

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 17 recalled by AMMAN PHARMACEUTICAL INDUSTRIES 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 17 products in this recall →

Same manufacturer · AMMAN PHARMACEUTICAL INDUSTRIES

See all →

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Same hazard · lack of sterility