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Class II: temporary or reversible health riskOngoing

Global Sanitizers MEDICALLY MINDED Hand Sanitizer Gel Recall

MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8

Global Sanitizers LLC · Las Vegas, NV

Risk level
Class II
Reported by FDA
Sep 8, 2021
Recall ID
D-0779-2021
Check your lot numberHow we source this data

Summary

Global Sanitizers recalled MEDICALLY MINDED Hand Sanitizer Gel starting May 12, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0779-2021 on Sep 8, 2021. Reason: 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. Status: Ongoing.

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.

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Product Distributed Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0779-2021
Classification
Class II
Status
Ongoing
Recall initiated
May 12, 2021
FDA report date
Sep 8, 2021
Quantity
50,000 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Global Sanitizers LLC

Original FDA data

Every field from FDA enforcement report D-0779-2021, exactly as published.

Show all FDA fields
City
Las Vegas
State
NV
Status
Ongoing
Country
United States
Event ID
87941
Address
5979 S Valley View Blvd
Code information
Lot No: E372020, "Best Buy": 5/21/2022;
Postal code
89118-3111
Report date
Sep 8, 2021
Product type
Drugs
Recall number
D-0779-2021
Classification
Class II
Recalling firm
Global Sanitizers LLC
Product 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.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Product Distributed Nationwide in the USA
Recall initiation date
May 12, 2021
Initial firm notification
Letter
Center classification date
Aug 30, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0779-2021, published Sep 8, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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