Sulfacetamide Sodium Suspension Recall
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Questions & Answers
Side Effects & Adverse Reactions
Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS section).
Sulfacetamide Sodium Topical Suspension USP, 10% contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than non-asthmatic people (see CONTRAINDICATIONS section).
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Sulfacetamide Sodium Topical Suspension USP, 10% is indicated in the topical treatment of acne vulgaris.
There is currently no drug history available for this drug.
Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% contains 100 mg of sulfacetamide sodium in a vehicle consisting of purified water, propylene glycol, lauramide DEA (and) diethanolamine, polyethylene glycol 400 monolaurate, hydroxyethyl cellulose, sodium chloride, sodium metabisulfite, methylparaben, xanthan gum, EDTA and simethicone. Sulfacetamide sodium is a sulfonamide with antibacterial activity. Chemically sulfacetamide sodium is N' -[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: