70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in US with US and forei...
FDA Recall #D-1151-2022 — Class II — June 15, 2022
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.
Reason for Recall
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.
Recalling Firm
Vi-Jon, LLC — Smyrna, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,157,620 bottles
Distribution
Nationwide in the USA
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated