Drug product
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04.
D-0455-2023
Product summary
- Event
- Event 91714
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 500 bottles
- Official record key
drug-enforcement:D-0455-2023
Official wording
Reason: Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Code information: All Lots
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination