70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in US with US and foreign components for Medli
Summary
The FDA issued a Class II for 70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in US by Vi-Jon, LLC. Reason: 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 i.
Details
Source
Drug Recall
External ID
D-1151-2022
Action Date
2022-06-29
Status
Terminated
Category
drug
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.
Lot/Code Info: 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
Quantity Affected: 3,157,620 bottles
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.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-15
Company
Smyrna, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 45 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Vi-Jon, LLC has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Vi-Jon, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vi-Jon, LLC have FDA actions?
Vi-Jon, LLC has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1151-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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