TRP Natural Eyes Sterile Eye Drops Recalled Due to Sterility Assurance
TRP Natural Eyes Allergy Eyes Relief Sterile Eye Drops (NDC 17312-032-15, Lot IY001) are recalled due to lack of assurance of sterility. Approximately 8,747 units 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 FDA Class II recall involves a sterile ophthalmic product with lack of assurance of sterility, representing a risk-of-harm product. No hospitalizations, illnesses, or adverse events have been reported in the source material. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops (Homeopathic, 0.33 FL OZ/10 mL, NDC 17312-032-15) manufactured by AMMAN PHARMACEUTICAL INDUSTRIES in Jordan exclusively for TRP Company, Inc., is being recalled.
The recall is due to lack of assurance of sterility in the manufacturing process. This manufacturing deficiency creates a potential contamination risk for a sterile ophthalmic product.
The affected lot number is IY001 with an expiration date of 07/24. Approximately 8,747 units were distributed to two direct accounts in Rhode Island and Colorado.
This Class II recall (FDA recall number D-1152-2023) has been issued to notify distributors and healthcare providers. Consumers who have obtained this product should consult with their healthcare provider.
The recalled product
- Product
- TRP Natural Eyes, Allergy Eyes 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: 17312-032-15.
- Manufacturer
- AMMAN PHARMACEUTICAL INDUSTRIES
- Category
- Drug — Ophthalmic
- Hazard
- contamination
- 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 (2)
- Lot: IY001
- EXP 07/24
Distribution
Distributed in 2 states:
- CO
- RI
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