M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kos
Summary
The FDA issued a Class I for M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 by MEDEK LLC. Reason: Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol..
Details
Source
Drug Recall
External ID
D-1342-2022
Action Date
2022-08-24
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: All lots
Quantity Affected: 256 bottles
Reason for Recall
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
Distribution
Texas
Type: Voluntary: Firm initiated
Recall Initiated: 2020-09-09
Company
Alamo, TX
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDEK LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDEK LLC have FDA actions?
This is the only FDA action we have on record for MEDEK LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1342-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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