OREM, Utah, Dec. 31, 2018 /PRNewswire/ -- Results RNA LLC is voluntarily recalling Lubrisine Eye Drops to the healthcare practitioner, retail or consumer level. This product, in a recent FDA inspection, was found to be manufactured using practices that do not support its sterility and contained undeclared colloidal silver.
Use of a non-sterile eye drop could result in a potentially sight threatening eye infection. Exposure to colloidal silver, over an extended period of time, could result in permanent discoloration of the conjunctiva. Results RNA has not received any reports of adverse events related to this recall. No illnesses have been reported regarding the product to date. The products can be identified by the following label and the lot number located on the bottom of the bottle.
The product is used to support lubrication of dry eyes and is packaged in a single 1oz dropper bottle with the UPC code 9238230723. The affected Lubrisine Eye Drops lots include all lots manufactured from May 12, 2012 forward. This date of manufacture is located on the bottom of the bottle.
Lubrisine Eye Drops were distributed Worldwide/Nationwide through healthcare practitioners, internet distributors, and the company's website to wholesale and retail customers.
Results RNA LLC notified its distributors and customers by email on December 14, 2018 announcing the Lubrisine Eye Drops recall with specific directions for returning all units of Lubrisine Eye Drops and how to obtain a refund applicable to the recalled product. Consumers with Lubrisine Eye Drops should stop using the product immediately.
Distributors, healthcare providers and consumers with questions regarding this recall can contact Results RNA LLC as follows:
Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm1
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
SOURCE Results RNA