The Recall Desk
HighFDA (Drugs)·D-1156-2023·Announced 2023-09-27

FDA Recalls TRP Natural Eyes Eye Drops for Sterility Concerns

FDA is recalling TRP Natural Eyes Dryness Relief eye drops due to lack of assurance of sterility. Approximately 83,898 units were distributed to accounts in Rhode Island and Colorado.

What this means for you

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 a sterile product with lack of assurance of sterility—a risk-of-harm product. No illnesses or injuries have been reported. Per the rubric, a risk-of-harm product without reported injury scores as High (3).

Plain-English summary

The FDA is recalling TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops (0.33 FL OZ / 10 mL bottles), manufactured by Amman Pharmaceutical Industries in Jordan and distributed exclusively by TRP Company, Inc. (1575 Delucchi Lane, Reno, Nevada). Product NDC: 17312-096-19.

The recall was issued because the manufacturer cannot assure that the product maintains its required sterile status. Non-sterile eye drops may be contaminated and pose a risk of serious eye infection if used.

Approximately 83,898 units were affected. The product was distributed to two direct customer accounts in Rhode Island and Colorado. Affected lots include: FR001 (expires 07/24), FR004 (expires 04/25), FR005 (expires 04/25), FR006 (expires 04/25), and FR007 (expires 04/25).

Consumers who have this product should stop using it immediately and discard it or return it to the point of purchase. Individuals who have used this product and experience eye discomfort, redness, or vision changes should consult a healthcare provider.

The recalled product

Product
TRP Natural Eyes, Dryness 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: 17312-096-19.
Manufacturer
AMMAN PHARMACEUTICAL INDUSTRIES
Category
Drug — Ophthalmic / Eye Drops
Hazard
  • lack-of-sterility

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 (5)

  • Lot: FR001 EXP: 07/24
  • Lot: FR004 EXP: 04/25
  • Lot:FR005 EXP: 04/25
  • Lot:FR006 EXP: 04/25
  • Lot: FR007 Exp: 04/25

Distribution

Distributed in 2 states:

  • CO
  • RI

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