D-0081-2021 Class II Ongoing

Recalled by Albek De Mexico S.A. De C.V. — San Juan Del Rio, N/A

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
19,992 bottles

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.

Distribution Pattern

USA Nationwide

Code Information

1931101AL