Pharmedica Eye Drop Recall

On March 3, 2023, Pharmedica voluntarily recalled specific lot numbers of Purely Soothing 15% MSM eye drops because of nonsterility. Consumers use the anti-inflammatory Pharmedica eye drops, formulated with methylsulfonylmethane, to reduce ocular irritation or swelling symptoms.

One month before the recall, on February 2, 2023, the FDA held a conference call with the owner of Pharmedica eye drops. The FDA recommended because of unsanitary conditions within the company’s manufacturing plant, that Pharmedica issue a recall for its Purely Soothing MSM Eye Drops and MSM nasal spray products.

Pharmedica voluntarily committed to stop manufacturing and distributing all drug products and to recall any products made with the active ingredient MSM on February 14, 2023. As of June 2023, Pharmedica hasn’t issued a recall for its Purely Soothing MSM Nasal Spray.

Although the FDA requested that Pharmedica voluntarily recall any drug products containing MSM, the company has only issued a recall notice for its MSM-based eye drops. Customers who have purchased Pharmedica nasal spray that contains MSM should speak with their doctor or pharmacist before using the product.

Consumers purchased Purely Soothing eye drops and nasal sprays with MSM on e-commerce websites, like Amazon, and via the company’s website purelysoothinghealth.com. Vendors also sell the products at trade shows. If you’ve purchased Purely Soothing eye drops or nasal sprays with MSM and are unable to contact the retailer to return the product, you can contact the company via email to initiate a return.

After the March 2023 Pharmedica MSM eye drops recall, the FDA issued a warning letter to the company in April. The warning letter addressed unsanitary conditions at the manufacturing plant for the products, violations of Current Good Manufacturing Practices. It also shared instructions for resuming manufacture.

Overall, the FDA investigation into Pharmedica’s facility uncovered significantly unsanitary conditions. Products that should be sterile were prepared, packed or held in unsanitary conditions. The investigator noted the facility was “in a state of disrepair.”

Currently the FDA hasn’t received reports of adverse effects connected to Pharmedica’s recalled MSM eye drops. Eye drops require a high level of sterility because users place them directly onto the mucus membrane of the eye. The body absorbs them quickly and easily. Unsterile eye drops can grow bacteria and cause serious eye infections, in some cases leading to blindness.

The possibility of nonsterile products can trigger a recall. In March 2023, Apotex issued a voluntary recall for six lots of its Brimonidine Tartrate Ophthalmic Solution 0.15% because of cracks on bottle lids. In February 2023, the FDA issued warnings about Ezricare and Delsam Pharma’s artificial tears because of CGMP violations, including a lack of microbial testing. The FDA warned that contamination from a drug-resistant bacteria strain that can cause vision loss and death was possible.

Consumers have also had questions about the safety of the active ingredient in Pharmedica’s products, MSM. It’s used in a variety of healthcare products, including oral supplements and topical creams. However, there haven’t been enough studies of MSM to determine long-term safety or how it interacts with other substances.

Speak to your doctor if you used recalled eye drops. Your doctor can help you monitor adverse reactions and give you advice about symptoms. You can also file a report with the FDA under their Adverse Events Reporting System.

People have filed eye drop injury lawsuits for infections linked to unsterile drops. Speak with an attorney experienced in drug injury litigation if you think you may have a case.