KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ
Summary
The FDA issued a Class II for KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Sus by KINDER FARMS LLC. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0143-2024
Action Date
2023-12-13
Status
Ongoing
Category
drug
Product Description
KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-096-02, UPC 850001805698.
Lot/Code Info: Lot #: CJ70902, Exp: 07/2024; CJ76275, WJ81412, Exp: 08/2024; WK02194, WK02196, WK04141, WK02873, WK05542, Exp: 10/2024; WK02874, WK04794, Exp: 01/2025; WK04793, WK06535, Exp: 03/2025.
Quantity Affected: 376,370 bottles
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-13
Company
Redondo Beach, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
KINDER FARMS LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (KINDER FARMS LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does KINDER FARMS LLC have FDA actions?
KINDER FARMS LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0143-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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