Isopropyl Alcohol Liquid
FDA Recall NDC 53329-798
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Isopropyl Alcohol (NDC 53329-798). A significant event, classified as Class II, was initiated on Jun 15, 2022 by Medline Industries, Lp. The reported reason for this action was: "Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.
Jun 15, 2022
Jun 29, 2022
3,157,620 bottles
Recall Profile & Regulatory Data
Event ID
90453
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Vi-Jon, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 05, 2024
Product Description
70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in US with US and foreign components for Medline Industries, Inc., Mundelein, IL 60060 USA, NDC: 53329-798-04, UPC (01) 10888277362291.
Batch or Lot Expiration Information
Lot# Lots #s: 0517418, Exp. 12/2022; 0506632, 0519195, 0522494, Exp. 01/2023; 0525627, 0525629, 0526051, 0526052, 0527664, 0527665, Exp. 03/2023; 0531133, 0531134, Exp. 04/2023; 0533153, 0534050, Exp. 05/2023; 0534585, 0534587, 0536089, Exp. 06/2023; 0538694, 0541334, Exp. 07/2023; 0539877, 0542355, Exp. 08/2023; 0545225, 0547054, 0547055, 0547131, Exp. 09/2023; 0547130, 0551014, 0551015, 0552608, Exp. 10/2023; 0552609, 0552610, 0553905, Exp. 11/2023; 0556144, 0557513, Exp. 12/2023; 0559594, 0559602, 0559603, Exp. 01/2024; 0551013, 0559596, 0559604, 0559605, 0561393, 0561395, Exp. 02/2024; 0556143, 0561396, 0561549, Exp. 03/2024; 0565877, Exp. 04/2024
Affected Packages Involved in this Recall
53329-798-03Product
53329-798-04Product
53329-798-23Product
53329-798-25Product
1088827736Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
