Agency classClass IIOur severity:High FDA (Drugs)·D-1153-2023·Announced 2023-09-27

TRP Natural Eyes sterile eye drops recalled due to lack of sterility assurance

AMMAN PHARMACEUTICAL INDUSTRIES is recalling TRP Natural Eyes Allergy Relief eye drops due to inability to assure sterility. The recalled lot includes 8,810 units distributed to 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: The source text does not report any illnesses, injuries, or hospitalizations. The hazard—lack of sterility assurance—represents a potential risk rather than confirmed harm. This FDA Class II recall without reported adverse effects meets the rubric criteria for a High severity score.

Plain-English summary

AMMAN PHARMACEUTICAL INDUSTRIES is recalling TRP Natural Eyes Allergy Relief PF sterile eye drops (10 mL, NDC 17312-097-19). The company cannot assure that the product meets required sterility standards for eye drops.

The recall affects 8,810 units from Lot FT001 (expiration date 07/24). The product was distributed to accounts in Rhode Island and Colorado.

If you have purchased this product, stop using it immediately. Contact your healthcare provider or pharmacist with any questions about this recall.

The recalled product

Product: TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-097-19.
Manufacturer: AMMAN PHARMACEUTICAL INDUSTRIES
Category: Drug — Eye Drops / Ophthalmic
Hazard: sterility-failure
contamination-risk
Affected units: 8,810

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: FT001
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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