Drug product
[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist. by: Amazon.com Services, LLC, Seattle, WA 98109.
D-0302-2025
Product summary
- Event
- Event 96475
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 25,932 bottles
- Official record key
drug-enforcement:D-0302-2025
Official wording
Reason: Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Code information: Lot 0643188, exp. date 10/22/2026
Distribution pattern: VA
Derived failure modes
-
Labeling or packaging
Labeling; Label Mixup