Agency classClass IIOur severity:High FDA (Drugs)·D-1166-2023·Announced 2023-09-27

TRP Natural Eyes Sterile Eye Ointment Recalled for Lack of Sterility Assurance

TRP Natural Eyes Sterile Eye Ointment is recalled 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 Class II recall for a sterile eye product with potential for serious health consequences due to lack of sterility assurance. No illnesses or injuries have been reported, making this a precautionary recall with theoretical risk.

Plain-English summary

TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment (0.33 FL OZ / 10 mL) manufactured by AMMAN PHARMACEUTICAL INDUSTRIES in Jordan is being recalled. The product is identified by NDC 17312-099-15 and marketed by TRP Company, Inc., 1575 Delucchi Lane, Reno, Nevada 89502.

The recall was initiated because the manufacturer cannot provide adequate assurance that the product meets sterility requirements. This is an FDA Class II recall, indicating potential for serious health consequences.

Approximately 8,819 units of lot DD001 (expiration July 2024) were distributed to two direct accounts in Rhode Island and Colorado. Consumers who have this product should stop using it and consult a healthcare provider if they have experienced any eye irritation, redness, or other symptoms following use. Healthcare providers and retailers with this product in stock should stop distribution and contact the manufacturer or the FDA for return instructions.

The recalled product

Product: TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-099-15.
Manufacturer: AMMAN PHARMACEUTICAL INDUSTRIES
Category: Drug — Sterile Eye Ointment
Hazard: contamination-risk
infection-risk
Affected units: 8,819

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 (1)

Lot:DD001 EXP: 07/24

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

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Same hazard · contamination risk