Pharmedica USA issues voluntary global recall of eye drops over non-sterility issue

The company’s Purely Soothing eye drop is used as an anti-inflammatory used to assist with symptoms of ocular irritation and/or swelling, including dry eye.

Purely Soothing, 15% MSM Drops are used to assist with symptoms of ocular irritation and/or swelling, including dry eye. (Image Credit: Adobe Stock/Piman Khrutmuang)

Purely Soothing, 15% MSM Drops are used to assist with symptoms of ocular irritation and/or swelling, including dry eye. (Image Credit: Adobe Stock/Piman Khrutmuang)

Pharmedica USA is recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level due to non-sterility. The use of contaminated eye drops can result in the risk of eye infections and vision loss.

According to an FDA news release, Pharmedica had not received any reports of adverse events or illness related to the recalled product at the time the recall was announced.

The eye drops were distributed worldwide by Purely Soothing via online e-commerce and Trade shows, like Amazon Marketplace.

According to the FDA news release, the eye drop is used as an anti-inflammatory to assist with symptoms of ocular irritation and/or swelling and is packaged in white, cylindrical HDPE bottles. The eye drops (LOT#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9) have eye dropper caps and white lids.

Pharmedica is advising customers to immediately stop using the product and return it to the place of purchase. Wholesalers and retailers should stop distributing/return to Pharmedica immediately or confirm that the product has been disposed of with proper verification.

Consumers with questions regarding this recall can contact Pharmedica USA LLC by phone number at 1-623-698-1752 or e-mail at osm@pharmedicausa.com.

Moreover, adverse reactions or quality problems experienced with the use of this product can be reported to the FDA's MedWatch Adverse Event Reporting program online.

This is the second such recall in a week.

Apotex Corp. initiated a voluntary recall for 6 lots of brimonidine tartrate ophthalmic solution, 0.15%, due to cracks that may have developed in some of the caps of the bottles.

In February, it was announced that the use of EzriCare Artificial Tears had been linked to 50 infections in 11 states that have led to individuals suffering permanent vision loss, hospitalization and 1 death, leading the US Centers for Disease Control (CDC) to urge health care providers and consumers to stop using the product.

According to a news release from the Centers for Disease Control and Prevention (CDC), it was investigating a multistate cluster of Verona Integron‐mediated Metallo‐β‐lactamase (VIM)‐ and Guiana‐Extended Spectrum‐β‐Lactamase (GES)‐ producing carbapenem‐resistant Pseudomonas aeruginosa (VIM‐GES‐CRPA) linked with multiple infection types, including eye infections. Recent epidemiology and laboratory evidence link these infections to use of EzriCare Artificial Tears.

“CDC recommends that clinicians and patients immediately discontinue the use of EzriCare Artificial Tears until the epidemiological investigation and laboratory analyses are complete,” the CDC said in its news release last month.

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