Drug 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.
D-1342-2022
Product summary
- Firm
- MEDEK LLC
- Event
- Event 86414
- Status
- Terminated
- Classification
- Class I
- Quantity
- 256 bottles
- Official record key
drug-enforcement:D-1342-2022
Official wording
Reason: Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
Code information: All lots
Distribution pattern: Texas
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination
-
Potency or specification failure
Subpotent