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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

Medtech Products, Inc.: New Baby Essentials Kit Recalled for Incorrect Ingredient Labeling

Agency Publication Date: March 13, 2019
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Summary

Medtech Products, Inc. is recalling 4,716 units of the Little Remedies New Baby Essentials Kit because the outer carton bears incorrect labeling for two of the five items contained within. The kit includes several infant products: Infant Fever Reducer (acetaminophen), Saline Spray/Drops, Gripe Water, Gas Relief Drops (simethicone), and Boudreaux's Butt Paste. Because the ingredients (excipients) are incorrectly listed or undeclared on the carton, parents and caregivers may not have accurate information about what is being administered to their child.

Risk

Incorrect labeling poses a risk of allergic reactions or adverse effects if an infant is sensitive to an undeclared ingredient or excipient. While no injuries have been reported, accurate labeling is critical for the safety of infant medications and topical treatments.

What You Should Do

  1. Check your packaging for the 'Little Remedies New Baby Essentials Kit' with UPC code 756184000076.
  2. Locate the Kit Lot Number and expiration date printed on the carton. This recall specifically affects Lot numbers 8473AG and 8473AI with an expiration date of 08/2020.
  3. If you have an affected kit, contact your pediatrician, healthcare provider, or pharmacist for guidance regarding the ingredients.
  4. Return any unused product to the place of purchase for a full refund.
  5. Contact the manufacturer, Medtech Products, Inc., for further instructions on the recall process.
  6. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332.

Your Remedy Options

๐Ÿ’ฐFull Refund

Full refund for returned kits.

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

Affected Products

Product: Little Remedies New Baby Essentials Kit
UPC Codes:
756184000076
Lot Numbers:
8473AG (Exp. 08/2020)
8473AI (Exp. 08/2020)
Date Ranges: Expiration 08/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82333
Status: Resolved
Manufacturer: Medtech Products, Inc.
Manufactured In: United States
Units Affected: 4,716 kits
Distributed To: Nationwide
Agency Last Updated: March 20, 2019

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.