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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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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Synergy Hand Sanitizer Recalled for High Impurity Levels

Agency Publication Date: September 15, 2022
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Summary

Superior Glove Works, Ltd. has recalled 7,296 bottles of Synergy Hand Sanitizer (80% Alcohol Topical Solution) because FDA analysis found levels of acetaldehyde and other impurities that exceeded safety specifications. This recall affects the 8.5 oz. (250 mL) bottles, which are non-sterile antiseptic solutions intended to reduce bacteria when soap and water are not available. No incidents or injuries have been reported to date, and the firm initiated the recall after CGMP deviations were identified.

Risk

Acetaldehyde is a chemical impurity that, when present above specification limits, can pose a risk of adverse health effects or skin irritation. Consumers using this product are exposed to higher-than-permitted levels of these impurities, which do not meet FDA safety standards for antiseptic drug products.

What You Should Do

  1. The recalled product is Synergy Hand Sanitizer (Alcohol 80% Topical Solution) sold in 8.5 oz. (250 mL) bottles with UPC 779406201594 and lot number 200513TA (Expiration Date 05/2023).
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Superior Glove Works, Ltd. for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) 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: Synergy Hand Sanitizer (8.5 oz. / 250 mL)
Variants: Alcohol 80% Topical Solution, Antiseptic, Non-Sterile Solution
UPC Codes:
779406201594
Lot Numbers:
200513TA (Exp. 05/2023)

Quantity: 7,296 bottles

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90827
Status: Resolved
Manufacturer: SUPERIOR GLOVE WORKS, LTD.
Sold By: Superior Glove Works Ltd.
Manufactured In: Canada
Units Affected: 7,296 bottles
Distributed To: Nationwide

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 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.