Little Remedies New Baby Essentials Kit recalled over undeclared excipients

Recall date

March 7, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Medtech Products, Inc. recalls Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little Remedies Infant Fev…

Recall number

D-1012-2019

FDA classification

Class II

Brand / firm

Medtech Products, Inc.

Sold / distributed

Nationwide in the United States.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.