FDA Drug recall D-1012-2019
Little Remedies New Baby Essentials Kit
- FDA Drug
- Class II
- terminated
- Published 2019-03-20
On 2019-03-20 the FDA classified a Class II recall of Little Remedies New Baby Essentials Kit by Medtech Products, citing incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1012-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-07 |
| Published | 2019-03-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Medtech Products |
| Distribution | US |
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
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Identifiers
| upc | 756184000076 |
|---|---|
| code_info | Kit Lot #: 8473AG, 8473AI, Exp. 08/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1012-2019%22
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