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Recall Observatory FDA recall evidence

Drug product

Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.

D-0600-2025

July 07, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 97385
Status
Ongoing
Classification
Class II
Quantity
6669874 swabs
Official record key
drug-enforcement:D-0600-2025

Official wording

Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

Code information: 61224040057

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent