TRP Eye Strain Relief Eye Drops Recalled Due to Lack of Sterility Assurance
Optikem International recalls TRP Eye Strain Relief eye drops nationwide due to lack of assurance of sterility. Affected units are 10 mL bottles with Lot E206.
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 sterile eye drops due to lack of assurance of sterility, representing a risk-of-harm to users. No illnesses or injuries have been reported in the source material, which limits the severity to High rather than Severe.
Plain-English summary
Optikem International, Inc. is recalling TRP Eye Strain Relief sterile eye drops (10 mL bottles, 0.33 FL OZ) distributed nationwide in the USA. The affected product is identified by NDC # 17312-172-15 and Lot # E206 with an expiration date of 09-21-2025. A total of 10,536 bottles are affected.
The product is being recalled due to lack of assurance of sterility. Sterile eye drops must be manufactured under strict controls to ensure they are free of contamination. The manufacturer has determined that the manufacturing process did not provide adequate assurance that sterility standards were met.
The affected product was distributed nationwide in the USA. Any person who has purchased this product should stop using it immediately.
Consumers who have obtained this product should consult with their healthcare provider regarding safe alternatives. Healthcare providers and consumers may report adverse events or side effects to the FDA.
The recalled product
- Product
- TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.
- Manufacturer
- Optikem International, Inc.
- 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 (2)
- Lot #: E206
- Exp: 09-21-2025
Distribution
Distributed nationwide across the United States.
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