Recalls / Class II
Class IID-0081-2021
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
- Affected lot / code info
- 1931101AL
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
- 19,992 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-0081-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.