TRP Natural Eyes Pink Eye Relief drops recalled for sterility assurance issues
TRP Natural Eyes Pink Eye Relief sterile eye drops (Lot FP001, expires 07/24) are being recalled due to lack of assurance of sterility. Consumers with this product should stop using it and consult their healthcare provider.
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: FDA Class II recall for a sterile pharmaceutical product where the manufacturer cannot assure sterility specifications. While no illnesses have been reported, eye drops are applied directly to sensitive eye tissue, making this a high-risk product category that meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
TRP Natural Eyes Pink Eye Relief PF is a sterile eye drop product indicated for pink eye relief. The product comes in 0.33 FL OZ (10 mL) bottles and is manufactured by Amman Pharmaceutical Industries in Jordan for TRP Company, Inc.
The recall was initiated because the manufacturer could not provide adequate assurance that the product maintains its sterility specifications. Eye drops must be sterile to prevent serious eye infections.
The affected product has the lot number FP001 with an expiration date of 07/24 and NDC 17312-094-19. Only limited distribution occurred—the product was distributed to two accounts in Rhode Island and Colorado.
Consumers who have purchased this product should discontinue use immediately and dispose of it safely. Anyone who has used this product and experiences eye discomfort, redness, or other symptoms should contact their healthcare provider.
The recalled product
- Product
- TRP Natural Eyes, Pink Eye 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: 17312-094-19.
- Manufacturer
- AMMAN PHARMACEUTICAL INDUSTRIES
- Category
- Drug — Eye drops / Ophthalmic
- Hazard
- sterility-failure
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: FP001 EXP:07/24
Distribution
Distributed in 2 states:
- CO
- RI
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