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Recall Observatory FDA recall evidence

Drug 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.

D-0143-2024

November 13, 2023

Class II

Product summary

Firm
KINDER FARMS LLC
Event
Event 93448
Status
Ongoing
Classification
Class II
Quantity
376,370 bottles
Official record key
drug-enforcement:D-0143-2024

Official wording

Reason: Failed Impurities/Degradation Specifications

Code 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.

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications