United States
Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. This product is being recalled due to non-sterility. To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product. Product was distributed Worldwide by Purely Soothing LLC via online e-commerce and Trade shows (Ex. Amazon Marketplace, Etc.).
Risk Statement: Use of contaminated eye drops can result in the risk of eye infections that could result in blindness.The eye drop is used as an anti-inflammatory aimed 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. The product can be identified by the labels attached.
Pharmedica USA LLC 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 USA LLC immediately or confirm that the product has been disposed of with proper verification.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Pharmedica USA LLC
Brand name: Purely Soothing
Product recalled: 15% MSM Drops
Reason of the recall: Non-sterility
FDA Recall date: March 03, 2023
Source:
www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharmedica-usa-llc-issues-voluntary-worldwide-recall-purely-soothing-15-msm-drops-due-non-sterility
