Why it was recalled
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Product description
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.
Lot numbers, UPCs & expiration codes
Kit Lot #: 8473AG, 8473AI, Exp. 08/2020
Where it was sold
Nationwide in the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1012-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 7, 2019
- FDA report date
- Mar 20, 2019
- Quantity
- 4,716 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medtech Products, Inc.
Original FDA data
Every field from FDA enforcement report D-1012-2019, exactly as published.
Show all FDA fields
- City
- Tarrytown
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 82333
- Address
- 660 White Plains Rd Ste 250
- Code information
- Kit Lot #: 8473AG, 8473AI, Exp. 08/2020
- Postal code
- 10591-5171
- Report date
- Mar 20, 2019
- Product type
- Drugs
- Recall number
- D-1012-2019
- Classification
- Class II
- Recalling firm
- Medtech Products, Inc.
- Product quantity
- 4,716 kits
- Termination date
- Nov 18, 2020
- Reason for recall
- Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the United States.
- Recall initiation date
- Mar 7, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 20, 2019