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.
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
Lot numbers, UPCs & expiration codes
1931101AL
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0081-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 30, 2020
- FDA report date
- Nov 25, 2020
- Quantity
- 19,992 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Albek De Mexico S.A. De C.V.
Original FDA data
Every field from FDA enforcement report D-0081-2021, exactly as published.
Show all FDA fields
- City
- San Juan Del Rio
- Status
- Ongoing
- Country
- Mexico
- Event ID
- 86162
- Address
- Oriente Cuatro No. 11 Nuevo
- Code information
- 1931101AL
- Report date
- Nov 25, 2020
- Product type
- Drugs
- Recall number
- D-0081-2021
- Classification
- Class II
- Recalling firm
- Albek De Mexico S.A. De C.V.
- Product 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jul 30, 2020
- Initial firm notification
- Press Release
- Center classification date
- Nov 17, 2020