Recall Record

Smyrna, TN, United States

Vi-Jon, LLC recalls

10 recalls recorded since 2018, most recently on 5 September 2023. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls10
Ongoing (FDA)0
Terminated or completed10
Class I (FDA)2

Terminated Class III Drugs

Recall started
5 September 2023
Terminated
29 January 2025
Reason
Incorrect/Undeclared Excipients.
Distribution
The consignee list includes one distributor with seven distribution centers. No product was sold under government contract. No product was sold to any federal, state, or local agency in the school lunch program.
Initiated
Voluntary: Firm initiated
Recall number
D-1173-2023

Terminated Class I, Class II Drugs

Recall started
15 July 2022
Terminated
9 May 2024
Reason
Microbial contamination of non-sterile products.
Distribution
Distributed Nationwide in the USA as well as Canada and Panama.
Initiated
Voluntary: Firm initiated
Recall numbers
D-1509-2022, D-1503-2022, D-1505-2022, D-1511-2022, D-1513-2022, D-1504-2022, D-1507-2022, D-1506-2022, D-1500-2022, D-1512-2022, D-1510-2022, D-1508-2022 and 2 more

Terminated Class II Drugs

Recall started
28 June 2022
Terminated
30 April 2024
Reason
Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
Distribution
Nationwide in the USA and Canada
Initiated
Voluntary: Firm initiated
Recall number
D-1244-2022

Terminated Class II Drugs

Recall started
24 June 2022
Terminated
17 June 2024
Reason
Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.
Distribution
USA Nationwide
Initiated
Voluntary: Firm initiated
Recall number
D-1191-2022

Terminated Class II Drugs

Recall started
15 June 2022
Terminated
5 July 2024
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 insufficient tightening.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-1151-2022

Terminated Class I Drugs

Recall started
13 June 2022
Terminated
6 May 2024
Reason
Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
Distribution
Distributed Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-1175-2022

Terminated Class II Drugs

Recall started
5 May 2022
Terminated
5 July 2024
Reason
Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0970-2022

Terminated Class II Drugs

Recall started
2 March 2022
Terminated
15 August 2023
Reason
Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.
Distribution
Product was distributed to one distributor in Texas for further distribution
Initiated
Voluntary: Firm initiated
Recall number
D-0644-2022

Terminated Class II Drugs

Recall started
9 September 2021
Terminated
21 June 2023
Reason
Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces
Distribution
Distributed Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0799-2021

Terminated Class II Drugs

Recall started
20 February 2019
Terminated
8 May 2020
Reason
Cross Contamination: Presence of IPA in finished product.
Distribution
Distributed in Ohio
Initiated
Voluntary: Firm initiated
Recall number
D-0520-2019

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.