Recalls / Class II
Class IID-1012-2019
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.
- Affected lot / code info
- Kit Lot #: 8473AG, 8473AI, Exp. 08/2020
Why it was recalled
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Recalling firm
- Firm
- Medtech Products, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 660 White Plains Rd Ste 250, N/A, Tarrytown, New York 10591-5171
Distribution
- Quantity
- 4,716 kits
- Distribution pattern
- Nationwide in the United States.
Timeline
- Recall initiated
- 2019-03-07
- FDA classified
- 2019-03-20
- Posted by FDA
- 2019-03-20
- Terminated
- 2020-11-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1012-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.