Recalls / Class II
Class IID-0082-2021
Product
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
- Affected lot / code info
- Lots ending in 1001,1002, 1003, 1004, 1005.
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.
Recalling firm
- Firm
- Albek De Mexico S.A. De C.V.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- Oriente Cuatro No. 11 Nuevo, N/A, San Juan Del Rio, N/A N/A, Mexico
Distribution
- Quantity
- 4,598,788 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2020-07-30
- FDA classified
- 2020-11-17
- Posted by FDA
- 2020-11-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0082-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.