PlainRecalls
FDA Drug Moderate Class II Ongoing

Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597

Reported: November 25, 2020 Initiated: July 30, 2020 #D-0081-2021

Product Description

Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597

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.

Details

Units Affected
19,992 bottles
Distribution
USA Nationwide
Location
San Juan Del Rio, N/A

Frequently Asked Questions

What product was recalled?
Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597. Recalled by Albek De Mexico S.A. De C.V.. Units affected: 19,992 bottles.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 25, 2020. Severity: Moderate. Recall number: D-0081-2021.