Why it was recalled
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
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.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Texas
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1342-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 9, 2020
- FDA report date
- Aug 24, 2022
- Quantity
- 256 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MEDEK LLC
Original FDA data
Every field from FDA enforcement report D-1342-2022, exactly as published.
Show all FDA fields
- City
- Alamo
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 86414
- Address
- 315 E Business Highway 83
- Code information
- All lots
- Postal code
- 78516-9627
- Report date
- Aug 24, 2022
- Product type
- Drugs
- Recall number
- D-1342-2022
- Classification
- Class I
- Recalling firm
- MEDEK LLC
- Product quantity
- 256 bottles
- Termination date
- Aug 23, 2024
- Reason for recall
- Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Texas
- Recall initiation date
- Sep 9, 2020
- Initial firm notification
- Press Release
- Center classification date
- Aug 15, 2022