FDA Drug Recalls

Recalls / Class I

Class ID-0781-2021

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

Product

MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1

Affected lot / code info
Lot No: E082020, "Best Buy": 5/21/2022

Why it was recalled

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.

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-0781-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.