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Recall Observatory FDA recall evidence

Drug 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 ,

D-0782-2021

May 12, 2021

Class II

Product summary

Firm
Global Sanitizers LLC
Event
Event 87941
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0782-2021

Official wording

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.

Code information: Lot No: E212020, "Best Buy": 5/21/2022

Distribution pattern: Product Distributed Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    found to contain methanol
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations