Medtech Recalls Little Remedies New Baby Essentials Kit for Labeling Errors
Medtech Products is recalling 4,716 Little Remedies New Baby Essentials Kits because the cartons contain incorrect labeling for two of the five items inside.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as incorrect labeling without reporting any illnesses, injuries, or specific hazardous excipients, fitting the criteria for minor labeling errors.
Plain-English summary
Medtech Products, Inc. is recalling 4,716 units of the Little Remedies New Baby Essentials Kit. The kits were distributed nationwide in the United States. Each kit contains five products: Little Remedies Infant Fever Reducer, Little Remedies Saline Spray/Drops, Little Remedies Gripe Water, Little Remedies Gas Relief Drops, and Boudreaux's Butt Paste.
The recall is due to incorrect labeling on the kit cartons for two of the five items contained within. The affected kits have Lot numbers 8473AG and 8473AI and an expiration date of 08/2020. The UPC for the product is 7 56184 00007 6.
Consumers should check their inventory for these specific lot numbers and expiration dates. If they have the affected kits, they should stop using them and contact Medtech Products, Inc. for instructions on how to return the product or obtain a refund.
The recalled product
- 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…
- Manufacturer
- Medtech Products, Inc.
- Category
- Drug — OTC Medications
- Hazard
- Affected units
- 4,716
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Kit Lot #: 8473AG
- 8473AI
- Exp. 08/2020
Distribution
Distributed nationwide across the United States.
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