MuGard

Soleva Pharma LLC · Model Mucoadhesive Oral Wound Rinse · UDI-DI 00860013569907

OLR MGQ Prescription

510(k) clearances

Adverse events (3 deaths)

Recalls

Facilities

Description

MuGard Mucoadhesive Oral Wound Rinse (MuGard) is a non-sterile slightly viscous liquid consisting of film-forming polymers, humectant and dispersion aids, preservatives, sweeteners/flavors and pH modifiers, namely: carbomer homopolymer A, polysorbate 60, glycerin, benzyl alcohol, citric acid, sodium saccharin, potassium hydroxide, and phosphoric acid. The rinse solution is supplied in a flat, white, opaque, eight fluid ounce, high-density polyethylene (HDPE) bottle.

Recalls

Date	Firm	Reason
2022-02-21	SA3, LLC	Due to failure of microbial testing for total aerobic microbial count (TAMC).

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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.