Why it was recalled
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Product description
NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3
Lot numbers, UPCs & expiration codes
Lots ending in 1001,1002, 1003, 1004, 1005.
Where it was sold
USA Nationwide
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-0082-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 30, 2020
- FDA report date
- Nov 25, 2020
- Quantity
- 4,598,788 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Albek De Mexico S.A. De C.V.
Original FDA data
Every field from FDA enforcement report D-0082-2021, exactly as published.
Show all FDA fields
- City
- San Juan Del Rio
- Status
- Ongoing
- Country
- Mexico
- Event ID
- 86162
- Address
- Oriente Cuatro No. 11 Nuevo
- Code information
- Lots ending in 1001,1002, 1003, 1004, 1005.
- Report date
- Nov 25, 2020
- Product type
- Drugs
- Recall number
- D-0082-2021
- Classification
- Class II
- Recalling firm
- Albek De Mexico S.A. De C.V.
- Product quantity
- 4,598,788 bottles
- Reason for recall
- CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jul 30, 2020
- Initial firm notification
- Press Release
- Center classification date
- Nov 17, 2020