FDA recall D-0644-2022

Vi-Jon, Inc. · Class II · drug

Product

HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles with brown colored closures. Distributed by HEB San Antonio, TX 78204. UPC 0 41220 25111 7

Reason for recall

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

Key facts

Status: Terminated
Initiation date: 2022-03-02
Report date: 2022-03-09
Termination date: 2023-08-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Smyrna, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0644-2022