Why it was recalled
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Product description
MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00417 8
Lot numbers, UPCs & expiration codes
Lot No: GV4420205 Best By, 5/21/2022
Where it was sold
Product Distributed Nationwide in the USA
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-0778-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 12, 2021
- FDA report date
- Sep 8, 2021
- Quantity
- 50,000 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Global Sanitizers LLC
Original FDA data
Every field from FDA enforcement report D-0778-2021, exactly as published.
Show all FDA fields
- City
- Las Vegas
- State
- NV
- Status
- Ongoing
- Country
- United States
- Event ID
- 87941
- Address
- 5979 S Valley View Blvd
- Code information
- Lot No: GV4420205 Best By, 5/21/2022
- Postal code
- 89118-3111
- Report date
- Sep 8, 2021
- Product type
- Drugs
- Recall number
- D-0778-2021
- Classification
- Class II
- Recalling firm
- Global Sanitizers LLC
- Product quantity
- 50,000 bottles
- Reason for recall
- CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00417 8
- Distribution pattern
- Product Distributed Nationwide in the USA
- Recall initiation date
- May 12, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 30, 2021