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
Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico. UPC 0 32251 49935 7
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-0028-2021
- 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-0028-2021, 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-0028-2021
- 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
- Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico. UPC 0 32251 49935 7
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jul 11, 2020
- Initial firm notification
- Press Release
- Center classification date
- Oct 7, 2020