Summary
- Company announcement date:
- FDA Publication Date:
- Kind of product:
- Drugs
- Reason for announcement:
-
Description of the reason for withdrawal
Due to the instability of paracetamol
- Company Name:
- Kinder Farms, LLC
- Brand Name:
- Product description:
-
Product description
Over-the-counter pain reliever and fever reliever for babies and children
company announcement
FOR IMMEDIATE RELEASE - November 13, 2023, Los Angeles, California: KinderFarms, LLC is voluntarily recalling all lots of KinderMed Infants' Pain & Fever (oral suspension) and KinderMed Kids' Pain & Fever (oral suspension) at the retail and consumer level. These products are being voluntarily withdrawn from the market due to the instability of paracetamol. The two products were manufactured and packaged for KinderFarms by a leading US-based over-the-counter pharmaceutical manufacturer with over 30 years of experience. Ongoing testing of sample lots indicated that some product lots no longer met specifications and could pose a health risk. Out of an abundance of caution, KinderFarms has made the decision to voluntarily recall all KinderMed Pain & Fever products.
Paracetamol is the active ingredient in many pain relievers. As a result of the potential health risk posed by off-specification paracetamol, the product may cause acute adverse health effects such as abdominal pain, nausea, vomiting or jaundice at higher doses. To date, the company has not received any reports of serious adverse events from any of these products. This recall does not affect any other KinderFarms products.
The affected product being voluntarily recalled includes lots of:
- KinderMed Infants' Pain & Fever (2 fl oz/59 mL), (acetaminophen - 160 mg per 5 mL), oral suspension
UPC: 850001805698 - KinderMed Kids' Pain & Fever (4 fl oz/118 mL), (acetaminophen - 160 mg per 5 mL), oral suspension
UPC: 850001805728
This voluntary recall covers all products currently available on shelves of these two SKUs only. These products are available nationwide at pharmacies, supermarkets, direct delivery and national retailers, and online through major e-commerce sites.
Consumers who purchased either of these two products should stop using them and can return the product to the place of purchase for a full refund.
Consumers with questions can contact the company at consumerrelations@kinderfarms.com or 800-996-2930 from 6:00 am to 5:00 pm (Pacific time).
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program, either online, by mail, or by fax.
This recall is being conducted with the knowledge of the US Food and Drug Administration.
For media inquiries, please contact Aurora Gonzรกlez at aurora@leveecommunications.com.
