Reported Mar 20, 2019 · Terminated

Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little Remedies Infant…

Medtech Products, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtech Products, Inc. · 660 White Plains Rd Ste 250 · Tarrytown, NY · 10591-5171

Is this the product you have?

  • Little Remedies New Baby Essentials Kit. Each kit contains 1
  • each of the following productsLittle Remedies Infant Fever Reducer (acetaminophen 150mg) 2 fl. oz. bottle, Little Remedies Saline Spray/Drops (sodium chloride) 0.5 fl oz., Little Remedies Gripe Water (zingiber officinale (Ginger) Root Extract 5mg, Foeniculum vulgare (Fennel) Seed Extract 4 mg) 2 fl. oz bottle., Little Remedies Gas Relief Drops (simethicone emulsion USP 66.7 mg and simethicone 20 mg) 1 fl. oz., Boudreaux's Butt Paste (zinc oxide 16%) 2 oz. ointment,. Distributed by Medtech Products Inc. Tarrytown, NY, a Prestige Consumer Healthcare Company. UPC 7 56184 00007 6
Lot codes and dates
    • Kit Lot #: 8473AG
    • 8473AI
    • Exp. 08/2020
Amount recalled
4,716 kits

Where it was sold

  • Nationwide

Why it was recalled

Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 18, 2020 · Data as of Sep 19, 5:46 PM UTC

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