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

FDA Recall #D-0779-2021 — Class II — May 12, 2021

Recall #D-0779-2021 Date: May 12, 2021 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Global Sanitizers LLC — Las Vegas, NV

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

50,000 bottles

Distribution

Product Distributed Nationwide in the USA

Code Information

Lot No: E372020, "Best Buy": 5/21/2022;

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated