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NeilMed Sinus Rinse Refill Box

NEILMED PHARMACEUTICALS, INC. · Model Isotonic, 50ct Packets/Sachets · UDI-DI 00705928052000

KCJ

510(k) clearances

Adverse events

Recalls

133

Facilities

Description

Sinus Rinse products contain pre-weighed and sealed salt-soda mixture packets/sachets. The Kit variants also contain a bottle assembly (bottle, cap and tube that is affixed to the cap). The packets/sachets contain a defined ratio of sodium chloride and sodium bicarbonate that provides a pH balanced isotonic, solution the resulting saline solution is squirted through a bottle assembly designed at NeilMed Products, Inc. The regular Isotonic Sinus Rinse packets/sachets have salt concentration with a tonicity close to that of plasma or serum. The Isotonic Sinus Rinse Kit comes with a 240mL bottle premixed Packets/sachets containing a mixture of sodium chloride and sodium bicarbonate. This produces 0.9 % saline solution on mixing one packet with 240mL of water. The packets/sachets also come in an individual box

Recalls

Date	Firm	Reason
2024-12-28	Neilmed Pharmaceuticals Inc	Due to nasal spray stability failure for bioburden.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.