June 2022 FDA Recall Isopropyl Alcohol by Vi-jon, Llc
D-1151-2022 - Defective Container
This Class II drug recall was voluntarily initiated by Vi-jon, Llc on June 15, 2022 for the product Isopropyl Alcohol. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1151-2022
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.
06-15-2022
06-29-2022
3,157,620 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Vi-Jon, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
07-05-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
