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       #Post#: 2975--------------------------------------------------
       World Wide Recall
   DIR By: Road2HardCoreIron
       Date: March 7, 2023, 7:03 pm
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       Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely
       Soothing 15% MSM Drops Due to Non-Sterility
       March 3, 2023
       Audience: Consumer
       March 3, 2023 -- Phoenix, Arizona, USA; 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.
       Risk Statement: Use of contaminated eye drops can result in the
       risk of eye infections that could result in blindness.
       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.).
       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 below.
       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 with questions regarding this recall can contact
       Pharmedica USA LLC by phone number at +1 (623) 698 - 1752 or
       e-mail address at osm@pharmedicausa.com Monday to Friday between
       the hours of 8:00 AM MST (AZ) and 5:00 PM MST (AZ).. 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.
       Adverse reactions or quality problems experienced with the use
       of this product may be reported to the FDA's MedWatch Adverse
       Event Reporting program either online, by regular mail or by
       fax.
       Complete and submit the report Online
       Regular Mail or Fax: Download form or call 1- 800-332-1088 to
       request a reporting form, then complete and return to the
       address on the pre-addressed form, or submit by fax to
       1-800-FDA-0178
       This recall is being conducted with the knowledge of the U.S.
       Food and Drug Administration.
       Source: FDA
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