D-0644-2022 Class II Terminated
FDA drug recall D-0644-2022 was initiated by Vi-Jon, Inc. on Mar 2, 2022 and is designated Class II. 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… The recall status is terminated (terminated Aug 15, 2023). Affected quantity: 11,580 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 9, 2022
- Initiation Date
- Mar 2, 2022
- Termination Date
- Aug 15, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,580 bottles
Product Description
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 Pattern
Product was distributed to one distributor in Texas for further distribution
Code Information
Lot: 0546089 Exp. 09/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0644-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026