D-0082-2021 Class II Ongoing
FDA drug recall D-0082-2021 was initiated by Albek De Mexico S.A. De C.V. on July 30, 2020 and is designated Class II. 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 manufacture… The recall status is ongoing. Affected quantity: 4,598,788 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 25, 2020
- Initiation Date
- July 30, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,598,788 bottles
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
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.
Distribution Pattern
USA Nationwide
Code Information
Lots ending in 1001,1002, 1003, 1004, 1005.