FDA Recalls TRP Natural Eyes Eye Drops Due to Sterility Assurance Issue
The FDA is recalling TRP Natural Eyes Aging Eye Relief eye drops due to lack of assurance of sterility. The affected lot DB001 (expiration 06/24) was 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: This is an FDA Class II recall of sterile eye drops due to lack of assurance of sterility. While no illnesses or injuries have been reported in the source text, the product poses a potential risk of serious eye infection, qualifying it as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
TRP Natural Eyes, Aging Eye Relief Sterile Eye Drops is being recalled. The product is a homeopathic eye drop in 0.33 FL OZ (10 mL) bottles manufactured by Amman Pharmaceutical Industries in Jordan for TRP Company, Inc. The recalled lot is DB001 with an expiration date of 06/24, affecting 8,747 units.
The FDA has determined the product lacks assurance of sterility. This is a critical concern for ophthalmic products, as lack of sterility can result in contamination and serious eye infections.
The product was distributed to two direct accounts in Rhode Island and Colorado.
Consumers who have this product should discontinue use immediately. Contact TRP Company, Inc. or a healthcare provider if you have questions or concerns about this recall.
The recalled product
- Product
- TRP Natural Eyes, Aging Eye Relief, 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: 17312-027-15.
- Manufacturer
- AMMAN PHARMACEUTICAL INDUSTRIES
- Category
- Drug — Eye Drops / Ophthalmic
- Affected units
- 8,747
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#:DB001 EXP: 06/24
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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