Recalls / Class II
Class IID-0644-2022
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
- Affected lot / code info
- Lot: 0546089 Exp. 09/2023
Why it was recalled
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.
Recalling firm
- Firm
- Vi-Jon, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Swan Dr, Smyrna, Tennessee 37167-2099
Distribution
- Quantity
- 11,580 bottles
- Distribution pattern
- Product was distributed to one distributor in Texas for further distribution
Timeline
- Recall initiated
- 2022-03-02
- FDA classified
- 2022-03-03
- Posted by FDA
- 2022-03-09
- Terminated
- 2023-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0644-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.