Recall D-1342-2022
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.
Recall D-1342-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1342-2022 |
Event ID | 86414 |
Distribution | Texas |
Quantity | 256 bottles |
Recall Reason | Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol. |
Drug Classification | Class I |
Drug Code Info | 20220824 |
Recall Initiation Date | 20200909 |
Report Date | 20220824 |
Classification Date | 20220815 |
Address | 315 E Business Highway 83 Alamo, TX 78516-9627 United States |
Recalling Firm | MEDEK LLC |
Initial Notification | Press Release |
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