Consumer health companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Lee Pharmaceuticals with 29 510(k) clearances and 1 drug recall. The most recent is a drug recall dated Dec 21, 2012: 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled….
| Dec 21, 2012 | 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, ProudClass II · Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled d | Drug recalls |
| Mar 31, 1993 | RESTOBOND 4K924378 · KLE | 510(k) clearances |
| Jul 24, 1991 | PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERTK912256 · KLE | 510(k) clearances |
| Jun 28, 1990 | LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETSK900809 · DYW | 510(k) clearances |
| Oct 31, 1989 | RESTOBOND 3/DENTIN-ENAMEL BONDING AGENTK894315 · KLE | 510(k) clearances |
| Jul 1, 1988 | PROSTHODENT VLK881903 · EBF | 510(k) clearances |
| Jan 20, 1988 | LEE COMPOSITE INLAY SYSTEMK873123 · EBF | 510(k) clearances |
| Sep 25, 1986 | RESTODENT POSTERIORK863157 · EBF | 510(k) clearances |
| Jan 30, 1986 | PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORATK854882 · EBC | 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
