FDA Recall D-1342-2022
MEDEK LLC · Alamo, TX
Class I — life-threatening Terminated 1444 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-1342-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Texas
- Recall initiated
- 2020-09-09
- Classified by FDA Center
- 2022-08-15
- FDA published
- 2022-08-24
- Terminated
- 2024-08-23
- Recalling firm
- MEDEK LLC
- Firm location
- Alamo, TX