FDA Recall D-0289-2025

MEDLINE INDUSTRIES, LP - Northfield · Northfield, IL

Class II Ongoing 451 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30.

Lot / code: SKU: CUR090737RB, Lot: 61224050002

Quantity: 1,639,996 pads

Reason for recall

Subpotent Drug

Recall record

Recall number: D-0289-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Nationwide
Recall initiated: 2025-02-17
Classified by FDA Center: 2025-03-20
FDA published: 2025-03-26
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Firm location: Northfield, IL

Drug identification

Brand name(s): CURAD ALCOHOL PREP PADS
Generic name(s): ISOPROPYL ALCOHOL
Manufacturer(s): Medline Industries, LP
NDC(s): 53329-827
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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