D-1342-2022 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 24, 2022
- Initiation Date
- September 9, 2020
- Termination Date
- August 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 256 bottles
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.
Reason for Recall
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
Distribution Pattern
Texas
Code Information
All lots