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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

GCP Laboratories Inc: Major Infants' Gas Relief Drops Recalled for Microbial Contamination

Agency Publication Date: October 7, 2019
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Summary

Approximately 31,392 bottles of Major Infants' Gas Relief Drops (simethicone oral suspension) are being recalled because they may be contaminated with microorganisms. This non-sterile product is used to relieve pressure and bloating in infants, and the contamination could lead to infections. If you have this product, you should contact your healthcare provider or pharmacist for guidance on your child's health. You should return any unused product to the place of purchase for a refund and contact the manufacturer for further instructions.

Risk

The product may contain harmful microorganisms that can cause infections in infants, who may have developing or compromised immune systems. Using a contaminated oral medication poses a serious health risk to this vulnerable population.

What You Should Do

  1. Check your medicine cabinet for Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, sold in 1 FL OZ (30 mL) bottles.
  2. Identify if your product is affected by looking for Lot WBD003 with an expiration date of 03/21 and NDC 0904-5894-30 on the packaging.
  3. Immediately stop using the affected medicine and consult a healthcare provider or pharmacist if your child has used this product and you have health concerns.
  4. Return any unused portion of the recalled medication to the pharmacy or store where you purchased it for a full refund.
  5. Contact the manufacturer, GCP Laboratories Inc, for additional information or instructions regarding this recall.
  6. For further questions about food and drug safety, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Contact healthcare provider and return product

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP (30 mL)
Model:
NDC 0904-5894-30
Lot Numbers:
WBD003 (Exp. 03/21)
Date Ranges: Exp. 03/21

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83835
Status: Resolved
Manufacturer: GCP Laboratories Inc
Sold By: Major Pharmaceuticals
Manufactured In: United States
Units Affected: 31,392 30 mL 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 · 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.