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.
Product description
blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b) 7.5 fl. oz./221 ml bottle, UPC 8 14266 02362 4 b) 33.8 fl. oz./1L bottle, UPC 8 14266 02369 3, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.
Lot numbers, UPCs & expiration codes
All lots within expiry
Where it was sold
Distributed Nationwide in the USA
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-0023-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 11, 2020
- FDA report date
- Oct 7, 2020
- Quantity
- 17,359,247 total bottles and pumps
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- 4e Brands North America, Llc
Original FDA data
Every field from FDA enforcement report D-0023-2021, exactly as published.
Show all FDA fields
- City
- San Antonio
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 86022
- Address
- 17806 Ih-10 Ste 300
- Code information
- All lots within expiry
- Postal code
- 78257
- Report date
- Oct 7, 2020
- Product type
- Drugs
- Recall number
- D-0023-2021
- Classification
- Class II
- Recalling firm
- 4e Brands North America, Llc
- Product quantity
- 17,359,247 total bottles and pumps
- Termination date
- Feb 26, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b) 7.5 fl. oz./221 ml bottle, UPC 8 14266 02362 4 b) 33.8 fl. oz./1L bottle, UPC 8 14266 02369 3, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jul 11, 2020
- Initial firm notification
- Press Release
- Center classification date
- Oct 7, 2020