- Firm Announcement Date:
- FDA Publish Date:
- Product Kind:
- Purpose for Announcement:
Recall Purpose Description
Resulting from Acetaminophen Instability
- Firm Identify:
- KinderFarms, LLC
- Model Identify:
- Product Description:
OTC Ache and Fever Reliever for Infants and Children
FOR IMMEDIATE RELEASE – November 13, 2023, Los Angeles, California – KinderFarms, LLC is voluntarily recalling all plenty of KinderMed Infants’ Ache & Fever (oral suspension) and KinderMed Children’ Ache & Fever (oral suspension) to the retail and shopper degree. These merchandise are being voluntarily recalled as a consequence of acetaminophen instability. The 2 merchandise have been manufactured and packaged for KinderFarms by a serious, U.S.-based OTC pharmaceutical producer with over 30 years of expertise. Ongoing testing of pattern batches indicated some product tons have been now not in specification and will pose a well being threat. Out of an abundance of warning, KinderFarms has made the choice to voluntarily recall all KinderMed Ache & Fever merchandise.
Acetaminophen is the energetic ingredient in lots of pain-relieving medicines. Because of the potential well being threat with acetaminophen being outdoors of specification, the product could trigger acute antagonistic well being results, together with belly ache, nausea, vomiting or jaundice at increased doses. The corporate has not obtained any studies of significant antagonistic occasions from both of those merchandise up to now. No different KinderFarms merchandise are impacted by this recall.
The impacted product being voluntarily recalled is all plenty of:
- KinderMed Infants’ Ache & Fever (2 fluid ounces/59 mL), (Acetaminophen – 160 mg per 5 mL), Oral Suspension
- KinderMed Children’ Ache & Fever (4 fluid ounces/118 mL), (Acetaminophen – 160 mg per 5 mL), Oral Suspension
This voluntary recall encompasses all product at present out there on shelf of those two SKUs solely. These merchandise can be found nationwide in drug/pharmacy, supermarkets, direct supply and nationwide retailers, and on-line by way of main ecommerce websites.
Shoppers who bought both of those two merchandise ought to cease utilizing them and will return the product to the place of buy for a full refund.
Shoppers with questions could contact the corporate at email@example.com or 800-996-2930 from 6:00 AM to five:00 PM (Pacific Time).
Antagonistic reactions or high quality issues skilled with the usage of this product could also be reported to the FDA’s MedWatch Antagonistic Occasion Reporting program both on-line, by common mail or by fax.
This recall is being carried out with the information of the U.S. Meals and Drug Administration.
For media inquiries, attain out to Aurora Gonzalez at firstname.lastname@example.org.
Firm Contact Data