March 2019 FDA Recall Drug by Medtech Products, Inc.
D-1012-2019 - Incorrect/undeclared excipients

This Class II drug recall was voluntarily initiated by Medtech Products, Inc. on March 7, 2019 for the product Drug. The FDA reported the reason for recall as incorrect/undeclared excipients. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1012-2019

Reason for Recall
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Initiated
03-07-2019
Reported
03-20-2019
Quantity
4,716 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82333
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Medtech Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-18-2020
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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