Recalls / Class II
Class IID-0027-2021
Product
ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) 10 fL oz / 295 ml bottle, UPC 6 39277 49070 4, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico
- Affected lot / code info
- All lots within expiry
Why it was recalled
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.
Recalling firm
- Firm
- 4e Brands North America, Llc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 17806 Ih-10 Ste 300, N/A, San Antonio, Texas 78257
Distribution
- Quantity
- 17,359,247 total bottles and pumps
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-07-11
- FDA classified
- 2020-10-07
- Posted by FDA
- 2020-10-07
- Terminated
- 2024-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0027-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.