September 2020 FDA Recall Drug by Medek Llc
D-1342-2022 - Chemical Contamination and Subpotent Drug

This Class I drug recall was voluntarily initiated by Medek Llc on September 9, 2020 for the product Drug. The FDA reported the reason for recall as chemical contamination and subpotent drug. The product was distributed in Texas and the recall is currently terminated.

Recall Number: D-1342-2022

Reason for Recall
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
Initiated
09-09-2020
Reported
08-24-2022
Quantity
256 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86414
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
MEDEK LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-23-2024
Product Description About Product Description
Full technical description of the product.
M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Col. Rodriguez Reynosa, Tam, Mexico C.P. 88630, NDC Code: 77797-001-01, Distributed by: Medek, LLC 315 E. Business Hwy 83 Alamo, TX 78516, NDC Code: 75432-001-02.

Batch or Lot Expiration Information

Lot# All lots