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
- Affected units
- 83,898
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
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.
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