FDA Drug Recalls

Recalls / Class II

Class IID-0779-2021

Product

MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ (250 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 00414 7

Affected lot / code info
Lot No: E372020, "Best Buy": 5/21/2022;

Why it was recalled

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Recalling firm

Firm
Global Sanitizers LLC
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
5979 S Valley View Blvd, N/A, Las Vegas, Nevada 89118-3111

Distribution

Quantity
50,000 bottles
Distribution pattern
Product Distributed Nationwide in the USA

Timeline

Recall initiated
2021-05-12
FDA classified
2021-08-30
Posted by FDA
2021-09-08
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0779-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.