Multi-event November 2023 FDA Recall Infants Pain And Fever by Kinder Farms Llc
This Multi-event Class II drug recall was voluntarily initiated by Kinder Farms Llc on November 13, 2023 for the product Infants Pain And Fever. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0143-2024
Failed Impurities/Degradation Specifications
11-13-2023
12-13-2023
376,370 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
KINDER FARMS LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
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.
Affected Packages Involved in this Recall
Recall Number: D-0142-2024
Failed Impurities/Degradation Specifications
11-13-2023
12-13-2023
591,684 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
KINDER FARMS LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-097-04, UPC 850001805728.
Batch or Lot Expiration Information
Lot# Lot: CJ70900, CJ76796, Exp: 8/2024; CJ77051, Exp: 09/2024; WK02998, WK02997, WK04390, WK02999, Exp: 10/2024; WK03716, Exp:12/2024; WK05150, WK05151, WK07174, Exp:02/2025; WK05539, WK06534, Exp: 03/2025; WK10259, WK23040, Exp: 04/2025; WK27455, Exp: 08/2025.
