# FDA recall D-1012-2019

> **Medtech Products, Inc.** · Class II · drug recall initiated 2019-03-07.

## 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.

## Reason for recall

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

## Distribution

Nationwide in the United States.

## Key facts

- **Recall number:** D-1012-2019
- **Recalling firm:** Medtech Products, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-07
- **Report date:** 2019-03-20
- **Termination date:** 2020-11-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1012-2019

## Citation

> AI Analytics. FDA recall D-1012-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-1012-2019. Source: US FDA. Licensed CC0.

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