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
D-0644-2022
Product summary
- Firm
- Vi-Jon, Inc.
- Event
- Event 89706
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,580 bottles
- Official record key
drug-enforcement:D-0644-2022
Official wording
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.
Code information: Lot: 0546089 Exp. 09/2023
Distribution pattern: Product was distributed to one distributor in Texas for further distribution
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up