Lubrisine eye drops recalled for undeclared colloidal silver and sterility issues
Results RNA, LLC is recalling Lubrisine eye drops nationwide due to lack of sterility assurance and the presence of undeclared colloidal silver.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 per the rubric.
Plain-English summary
Results RNA, LLC is recalling 10,297 bottles of Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottles, distributed nationwide within the United States. The recall covers all lots of the product.
The recall was initiated because the product was found to contain undeclared colloidal silver and lacked sterility assurance. These issues were identified during the recall investigation.
Consumers who have purchased this product should stop using it immediately and contact the manufacturer for further instructions or a refund.
The recalled product
- Product
- Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4
- Manufacturer
- Results RNA, LLC
- Category
- Drug — Ophthalmic
- Affected units
- 10,297
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)
- All Lots
Distribution
Distributed nationwide across the United States.
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