Medicine recalls
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| The United States: Results RNA LLC issues voluntary worldwide/nationwide recall of Lubrisine Eye Drops due to manufacturing sterility concerns and undeclared colloidal silver |
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The US Food and Drug Administration (FDA) announces that 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. The affected Lubrisine Eye Drops lots include all lots manufactured from 12 May 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.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm629256.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Jan 4, 2019
Issued at HKT 17:00
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