FDA Recall D-0779-2021

Global Sanitizers LLC · Las Vegas, NV

Class II Ongoing 1828 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

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

Quantity: 50,000 bottles

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.

Recall record

Recall number: D-0779-2021
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Product Distributed Nationwide in the USA
Recall initiated: 2021-05-12
Classified by FDA Center: 2021-08-30
FDA published: 2021-09-08
Recalling firm: Global Sanitizers LLC
Firm location: Las Vegas, NV

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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