FDA Recall D-0081-2021

Albek De Mexico S.A. De C.V. · San Juan Del Rio, N/A

Class II Ongoing 2114 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: 1931101AL

Quantity: 19,992 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.

Recall record

Recall number: D-0081-2021
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: USA Nationwide
Recall initiated: 2020-07-30
Classified by FDA Center: 2020-11-17
FDA published: 2020-11-25
Recalling firm: Albek De Mexico S.A. De C.V.
Firm location: San Juan Del Rio, N/A, Mexico

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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