FDA recall D-1342-2022

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.

Reason for recall

Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.

Distribution

Texas

Key facts

Status

Terminated

Initiation date

2020-09-09

Report date

2022-08-24

Termination date

2024-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Alamo, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1342-2022