Home / Recalls / Medtech Products, Inc. / D-1012-2019

D-1012-2019 Class II Terminated

Recalled by Medtech Products, Inc. — Tarrytown, NY

Recall Details

Product Type
Drugs
Report Date
March 20, 2019
Initiation Date
March 7, 2019
Termination Date
November 18, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,716 kits

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the United States.

Code Information

Kit Lot #: 8473AG, 8473AI, Exp. 08/2020

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  • D-1834-2019 Class II — Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye (July 26, 2019)
  • D-1829-2019 Class II — Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bot (July 26, 2019)
  • D-1831-2019 Class II — Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3- (July 26, 2019)
  • D-1830-2019 Class II — Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display c (July 26, 2019)
  • D-1825-2019 Class II — Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03 (July 26, 2019)