Purely Soothing
Purely Soothing is used as an anti-inflammatory remedy to help with eye irritation or swelling. The product has been sold worldwide via e-commerce sites like Amazon, Pharmedica said. The drops come in white, cylindrical bottles with eye-dropper caps and a white lid. The Lot Numbers and UPC codes of the recalled products are:
- Lot Number: 2203PS01, 1 oz, UPC 7 31034 91379 9;
- Lot Number: 1808051, ½ oz, UPC 7 31034 91382 9
Loading...Purely Soothing Recall
Company Announcement
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
Questions & Answers
Side Effects & Adverse Reactions
Use of contaminated eye drops can result in the risk of eye infections that could result in blindness
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharmedica-usa-llc-issues-voluntary-worldwide-recall-purely-soothing-15-msm-drops-due-non-sterility#recall-announcement
Manufacturer Warnings
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.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
The eye drop is used as an anti-inflammatory aimed to assist with symptoms of ocular irritation and/or swelling.
History
There is currently no drug history available for this drug.
Other Information
There is currently no other information available for this drug.
Sources
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharmedica-usa-llc-issues-voluntary-worldwide-recall-purely-soothing-15-msm-drops-due-non-sterility#recall-announcement
