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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/Over-the-Counter

Little Remedies Gas Relief Drops Recalled for Bacterial Contamination

Agency Publication Date: June 17, 2024
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Summary

Little Remedies Gas Relief Drops (simethicone) are being recalled because test results confirmed the presence of Burkholderia cepacia bacteria, which occurred due to a personnel error during manufacturing. The recall affects 113,544 bottles of the 1 fl. oz. (30 mL) size sold with a dropper. Although the manufacturer reported that 100% of the units were recovered and controlled, consumers should check their medicine cabinets for the affected lot number.

Risk

The product may be contaminated with Burkholderia cepacia bacteria. Exposure to this bacteria can lead to serious respiratory infections or other illnesses, particularly in infants or individuals with weakened immune systems or chronic lung conditions.

What You Should Do

  1. This recall affects Little Remedies Gas Relief Drops (simethicone/antigas) packaged in 1 fl. oz. (30 mL) bottles with dropper, specifically Lot # 0855 with an expiration date of 8/31/2025.
  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 Denison Pharmaceuticals, LLC for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Little Remedies Gas Relief Drops (Simethicone/Antigas) (1 fl. oz.)
Variants: 30 mL bottle, Includes dropper
Lot Numbers:
0855 (Exp 8/31/2025)
NDC:
63029-103-02

Distributed by Medtech Products Inc., Tarrytown, NY 10591. Recall # D-0557-2024.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94712
Status: Resolved
Manufacturer: Denison Pharmaceuticals, LLC
Sold By: Medtech Products Inc.
Manufactured In: United States
Units Affected: 113,544 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.