If you have just purchased Purely Soothing 15% MSM eye drops produced by Pharmedica USA LLC, you will have to stop using them immediately. The products have been recalled in compliance with the Food and Drug Administration due to their non-sterility.
Eye Drops Recall
Purely Soothing eye drops are used as an anti-inflammatory to help with irritation or swelling of the eyes. However, the company released a statement stating that the drops have been contaminated and may even lead to blindness if used.
The affected eye drops were manufactured in Arizona, with around 2,900 produced, as mentioned in Gizmodo. The company stated that the contaminated products were sold in online retail stores such as Amazon Marketplace and Trade Shows.
In the event that a customer purchased the affected products, Pharmedica USA LLC advised that they stop using it immediately and return the item/s to the place of purchase. Wholesalers and retailers should also stop distributing contaminated eye drops.
All affected products must be returned to Pharmedica USA LLC to make sure that the product will be disposed of with proper verification, and so it will not be sold despite the non-sterility. The company is already working with agencies to make sure of the return of the said products.
The recalled Purely Soothing eye drops are packaged in white, cylindrical HDPE bottles. Buyers should check the lot number to ensure that the bottle they purchased is not included in the contaminated batch. The non-sterile products are the following:
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Lot #: 2203PS01, 1 oz, UPC 7 31034 91379 9
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Lot #: 1808051, ½ oz, UPC 7 31034 91382 9
For further questions, consumers may contact Pharmedica USA through its phone numbers at +1 (623) 698-1752 from Monday to Friday. The service will be available between 8:00 AM MST (AZ) and 5:00 PM MST (AZ).
What If I Already Used the Product?
Pharmedica claims that they have not received any reports of adverse events or illnesses caused by the non-sterile eye drops. However, you may report to the FDA's MedWatch Adverse Event Reporting program should you experience adverse reactions or quality problems.
The company also advised consumers who have experienced problems with affected eye drops to contact their physician or healthcare provider. To submit a report, buyers can do so online or by contacting the company through their email address at osm@pharmedicausa.com.
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Other Cases
This is not the first recall for eye drops within the week. Apotex Corp. also recalled their products for six lots of brimonidine tartrate ophthalmic solution, 0.15% due to the cracks that may be found in some of the caps of the bottles.
EzriCare Artificial Tears was also linked to 50 infections in 11 states back in February. The infections caused some of its users to suffer permanent vision loss, hospitalization, and even one death, according to Opthalmology Times.
The US Centers for Disease Control (CDC) urged healthcare providers and practitioners to refrain from using the product to avoid further incidents. They were also investigating infection types including eye infections, and evidence linked to the use of EzriCare Artificial Tears.
Related: The FDA Removes Animal Testing Requirement For Drugs Before Human Trials Begin
