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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Topical Products

Purely Soothing MSM Drops and Nasal Spray Recalled for Non-Sterility

Agency Publication Date: March 6, 2023
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Summary

Pharmedica USA, LLC is recalling 1,864 units of Purely Soothing 15% MSM Drops (Methylsulfonylmethane) and Purely Soothing MSM Nasal Spray (Methylsulfonylmethane) because the products are not sterile and were manufactured under poor quality control standards. Using non-sterile eye or nasal products can introduce harmful bacteria or fungi into the body, potentially leading to serious infections. These products were sold nationwide and worldwide through e-commerce platforms and trade shows.

Risk

The lack of sterility in these products poses a significant risk of infection to the eyes or nasal passages. These infections can be difficult to treat and may lead to severe complications, including vision loss or systemic illness.

What You Should Do

  1. This recall affects Purely Soothing 15% MSM Drops sold in 15 ml bottles (UPC 731034913829) and 30 ml bottles (UPC 731034913799), and Purely Soothing MSM Nasal Spray in 30 ml bottles (UPC 731034913805).
  2. Identify the recalled products by checking for lot numbers 1808051 or 2203PS01 with an expiration date of 01/01/2027 printed on the product label.
  3. If you have health concerns after using these products, contact your healthcare provider or pharmacist immediately.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Pharmedica USA, LLC at 480-390-1366 for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Purely Soothing 15% MSM Drops
Variants: 15 ml (.5 fl oz) bottle, 30 ml (1.014 fl oz) bottle
UPC Codes:
731034913829
731034913799
Lot Numbers:
1808051 (Exp 01/01/2027)
2203PS01 (Exp 01/01/2027)

Quantity affected: 869 (15 ml) and 1035 (30 ml) bottles.

Product: Purely Soothing MSM Nasal Spray, 15%
Variants: 30 ml (1.014 fl oz) bottle
UPC Codes:
731034913805
Lot Numbers:
1808051 (Exp 01/01/2027)

Quantity affected: 995 bottles.

Product Images

Retail unit label, Purely Soothing 15% MSM Drops, Net Wt. 30 ml

Retail unit label, Purely Soothing 15% MSM Drops, Net Wt. 30 ml

Retail unit label, Purely Soothing 15% MSM Drops, Net Wt. 15 ml

Retail unit label, Purely Soothing 15% MSM Drops, Net Wt. 15 ml

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91707
Status: Active
Manufacturer: Pharmedica USA, LLC
Sold By: e-commerce; trade shows
Manufactured In: United States
Units Affected: 2 products (a) 869 bottles; b) 1035 bottles; 995 bottles)
Distributed To: Nationwide
Agency Last Updated: March 10, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.