Drug 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.
D-1012-2019
Product summary
- Event
- Event 82333
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,716 kits
- Official record key
drug-enforcement:D-1012-2019
Official wording
Reason: Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Code information: Kit Lot #: 8473AG, 8473AI, Exp. 08/2020
Distribution pattern: Nationwide in the United States.
Derived failure modes
-
Labeling or packaging
incorrect labeling