DistributorLabelled 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 15, 2026, FDA's public records list Pharmacaribe with 4 510(k) clearances and 1 device recall. The most recent is a device recall dated Dec 29, 2015: PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative ….
| Dec 29, 2015 | PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only RClass II · Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+) | Device recalls |
| Mar 13, 2013 | PULMOSALK130091 · CAF | 510(k) clearances |
| Sep 1, 2010 | NESSI OTC SPACERK101532 · NVO | 510(k) clearances |
| Aug 17, 2010 | PHARMACARIBE INHALED SALINE SOLUTIONSK101424 · CAF | 510(k) clearances |
| Nov 20, 2009 | NESSI SPACERK091862 · NVO | 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
