FDA Drug Recalls

Recalls / Class II

Class IID-0783-2021

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 UPC: 6 76753 00420 8 ,

Affected lot / code info
Lot No: E332020, E212020 "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
N/A
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-0783-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls