4e Brands North America, Llc
FDA Regulatory Profile
Summary
- Total Recalls
- 10 (3 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0030-2021 | Class I | blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% | July 11, 2020 |
| D-0028-2021 | Class II | Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) b | July 11, 2020 |
| D-0024-2021 | Class II | blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl | July 11, 2020 |
| D-0029-2021 | Class I | blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl | July 11, 2020 |
| D-0025-2021 | Class II | blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL | July 11, 2020 |
| D-0031-2021 | Class I | blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as a) 3.4 fl oz | July 11, 2020 |
| D-0022-2021 | Class II | blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% | July 11, 2020 |
| D-0023-2021 | Class II | blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / | July 11, 2020 |
| D-0026-2021 | Class II | ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 | July 11, 2020 |
| D-0027-2021 | Class II | ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 23 | July 11, 2020 |