Product Safety Recalls

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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1342-2022
Event ID86414
DistributionTexas
Quantity256 bottles
Recall ReasonChemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
Drug ClassificationClass I
Drug Code Info20220824
Recall Initiation Date20200909
Report Date20220824
Classification Date20220815
Address315 E Business Highway 83
Alamo, TX 78516-9627
United States
Recalling FirmMEDEK LLC
Initial Notification Press Release
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