Consumer health companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list DermaCare, Inc. with 3 510(k) clearances, 2 drug recalls and 2 warning letters. The most recent is a warning letter dated Nov 3, 2025: Warning letter: Unapproved new drug, Labeling.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Nov 3, 2025 | Warning letter: Unapproved new drug, LabelingCDER | Warning letters |
| Sep 9, 2025 | Warning letter: Unapproved new drugCDER | Warning letters |
| Sep 17, 2012 | UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL), Distributed by TaClass II · Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification. | Drug recalls |
| Sep 17, 2012 | UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed by TClass II · Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification. | Drug recalls |
| Oct 24, 2006 | THERMACLEARK060653 · GEX | 510(k) clearances |
| Aug 11, 1989 | DERMACARE TIE HOLDERK893995 · KGS | 510(k) clearances |
| Nov 25, 1988 | DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEPK884656 · GEI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
