D-0026-2021 Class II Terminated
FDA drug recall D-0026-2021 was initiated by 4e Brands North America, Llc on July 11, 2020 and is designated Class II. Reason for recall: CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. The recall status is terminated (terminated February 26, 2024). Affected quantity: 17,359,247 total bottles and pumps.
Recall Details
- Product Type
- Drugs
- Report Date
- October 7, 2020
- Initiation Date
- July 11, 2020
- Termination Date
- February 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,359,247 total bottles and pumps
Product Description
ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49069 8 b) 10 fL oz / 296 ml bottle, UPC 6 39277 49069 8, Distributed by Geenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico
Reason for Recall
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
All lots within expiry