FDA recall D-0799-2021

Vi-Jon, Inc. · Class II · drug

Product

Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Dist. By The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-810-45, UPC 0 11110 37049

Reason for recall

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

Key facts

Status
Terminated
Initiation date
2021-09-09
Report date
2021-09-22
Termination date
2023-06-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Smyrna, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0799-2021