Drug product
MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00420 8,
D-0780-2021
Product summary
- Event
- Event 87941
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 50,000 bottles
- Official record key
drug-enforcement:D-0780-2021
Official wording
Reason: Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Code information: Lot No: E082020, "Best Buy": 5/21/2022
Distribution pattern: Product Distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination