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Home > Recalled Products > Drugs > Lack of Sterility > Lubrisine Eye Drops

Recall: Lubrisine Eye Drops

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On 2018-12-31, the FDA announced that Results RNA is conducting a recall on Eye Drops due to a possible lack of sterility. The recalled products were sold under the brand name(s) Lubrisine during an unspecified time period throughout the regions shown in the map below.

In recent months, there have been 2 drugs recalls due to potential lack of sterility, including eye relief drops, 0.5 oz. (15ml) bottle, sterile compounded drugs and more. Additionally, there have been 18 drug and medical device recalls due to other health hazards as well as 95 food recalls.

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Lubrisine Eye Drops, Extra Strength, 1 FL oz
Note: Images may not be available for every version. Please review the detailed description below.

Company Contact Information:

Name: Results RNA
Phone: 203-290-2992

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Detailed Recall Information



Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.

Product Description: Eye Drops

Brand Name(s): Lubrisine

Reason for Recall: Undeclared colloidal silver and lack of sterility assurance

Official Recall Date: 2018-12-31


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Additional information provided by the FDA.gov:

Results RNA LLC Issues Voluntary Worldwide/Nationwide Recall of Lubrisine Eye Drops Due to Manufacturing Sterility Concerns and Undeclared Colloidal Silver

For Immediate Release
December 31, 2018

Contact Consumers
Results RNA LLC Sam Gossett customercare@lubrisine.com 203-290-2992

Announcement

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:

Email

Submit all inquiries to customercare@lubrisine.com

Phone

Call: 203-290-2992

Available hours: 8am - 5pm MST

Mail

Results RNA, LLC

P.O. Box 93

New Hartford, CT 06057

Website: disclaimer iconwww.lubrisine.com

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 associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.


More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.

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