Medtech Products, Inc. recalls Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little Remedies Infant Feve
Recalled March 20, 2019 · FDA recall D-1012-2019 · Medtech Products
Hazard
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit. · FDA Class II
Units
4,716 kits
Sold at
Nationwide in the United States.
Description
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Product
Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little 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.
Manufacturer(s)
Medtech Products, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →