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Pharmedica USA Purely Soothing 15% MSM eye drops recalled due to non-sterility

Article

Contaminated Purely Soothing 15% MSM drops carry risk of eye infections that may result in vision loss. All consumers should stop use immediately.

Pharmedica USA LLC has voluntarily recalled two lots of Purely Soothing 15% MSM eye drops due to non-sterility at the consumer level. No adverse events or illness have been reported at the time of recall, but the FDA urges consumers to stop use of the drops and return bottles to the place of purchase. Retailers and wholesalers should immediately pause distribution and return stock to Pharmedica USA or verify proper disposal with the FDA.

Patients who experience irritation or signs of infection following use should immediately talk to their eye care provider. Optometrists should advise patients against use. Purely Soothing 15% MSM eye drops were distributed worldwide via e-commerce, so advise patients to check any drops they have purchased online.

The Purely Soothing 15% MSM eye drops are an anti-inflammatory topical solution that soothe ocular irritation and swelling. The white, cylindrical HDPE bottles are capped with droppers and white lids.

These drops can be identified by their LOT numbers (LOT#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9) and have eye dropper caps and white lids.

Consumers with questions regarding the recall can contact Pharmedica USA LLC via phone at 1-623-698-1752 or email at osm@pharmedicausa.com Monday through Friday between 8 am and 5 pm MST. Those experiencing any problems that may be related to the drug product should contact their physician or healthcare provider.

Consumers experiencing adverse reactions of quality problems after use of these eye drops may report to the FDA’s MedWatch Adverse Event Reporting program online, by mail, or by fax.

  • Report the problem online
  • Download the form to mail a report in, or call 1-800-FDA-0178 to request a form to complete and return to the address on the pre-addressed form, or submit it by fax to 1-800-FDA-0178
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