The FDA announced an urgent recall in cooperation with KinderFarms, LLC for a popular over-the-counter pain and fever reducer for infants and children. When tested, the medication was found to be unstable and may pose serious health risks for babies or children who consume it. Parents should diligently check their children’s medication against this recall and discontinue use immediately if they find their product is included in the notice.
As of the writing of this notice, no reports of adverse events related to the use of the medication have yet been reported.
SUMMARY
Date of Recall:
Announced: November 13, 2023
Public Notification: November 17, 2023
Name(s) of Drug:
KinderMed OTC Pain and Fever Reliever for Infants and Kids
Company Name:
KinderFarms, LLC
Drug Indication:
Pain
Fever
Product Description
KinderMed Pain and Fever Reliever’s active ingredient is acetaminophen. It is packaged in white plastic bottles with an affixed KinderMed label. The bottles are distributed in white boxes labeled with KinderMed. Both bear an image of a unicorn on the front and a rainbow on the side. Both 2oz and 4oz sizes are included in the recall. The medication was distributed nationwide at pharmacies, supermarkets, and online retailers such as www.Amazon.com.
Reason for Recall
Routine testing of the lots included found that some products were out of specification and may pose serious health risks related to infants and children receiving unstable dosages of acetaminophen.
Impacts
Babies or children who consume the unstable medication may experience serious health outcomes related to receiving more acetaminophen per dose than recommended. Symptoms may include:
- Abdominal pain
- Nausea
- Vomiting
- Jaundice
Recall Lot Information
Consumers should locate their medication packages and compare the numbers printed to those listed below. If they are a match, follow the instructions below to ensure proper participation in recall procedures.
Product Description |
UPC |
| KinderMed Infants’ Pain & Fever (2 fluid ounces/59 mL), (Acetaminophen – 160 mg per 5 mL), Oral Suspension | 850001805698 |
| KinderMed Kids’ Pain & Fever (4 fluid ounces/118 mL), (Acetaminophen – 160 mg per 5 mL), Oral Suspension | 850001805728 |
Have you found that your medication is part of the recall? Here’s what you should do:
Consumers
- Stop use immediately.
- Notify your child’s pediatrician right away. Report symptoms experienced by your child.
- Monitor your child’s health for any adverse symptoms and notify their pediatrician if any concerns are noted.
- Consumers may contact KinderFarms, LLC at 1-800-996-2930. They are available from 6:00 a.m. to 5:00 p.m. (PT). You can also contact them via email at consumerrelations@kinderfarms.com.
- If your child is currently experiencing or has experienced an adverse reaction to this medication (listed above), notify their pediatrician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock affected by the recall immediately.
- Contact KinderFarms, LLC at 1-800-996-2930, or you can utilize consumerrelations@kinderfarms.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock affected by the recall immediately.
- Contact KinderFarms, LLC at 1-800-996-2930, or you can utilize consumerrelations@kinderfarms.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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