The Recall Desk
CriticalFDA (Drugs)·D-0360-2019·Announced 2018-12-26

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
Hazard
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.

Related recalls

Same hazard · undeclared excipient

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