The Ritedose Corporation is conducting a voluntary recall of
0.083% Albuterol Sulfate Inhalation Solution, 3 mL (in 25, 30, and 60 unit dose
vials). This product is a prescription inhalation solution, administered via
nebulization, for the treatment and maintenance of acute asthma exacerbations
and exercise induced asthma in children and adults. This product is being
recalled because the 2.5 mg/3 mL single use vials are embossed with the wrong
concentration of 0.5 mg/ 3 mL and therefore, represents a potential significant
health hazard. The following lot numbers manufactured by The Ritedose
Corporation under NDC: 0591-3797-83, 0591-3797-30, and 0591-3797-60 are
included in the recall: 0N81, 0N82, 0N83, 0N84, 0NE7, 0NE8, 0NE9, 0NF0, 0P12,
0P13, 0P46, 0P47, 0PF0, and 0S15. No other Albuterol formulations or products
are included in this recall.
The product is packaged as a single use unit dose vials in a
protective foil overwrap packaged in a shelf carton. Only the unit dose vials
are incorrectly embossed as containing 0.5 mg/3 mL. The correct concentration
of 2.5 mg/3 mL is labeled on the primary foil overwrap pouches and shelf
cartons. This product was distributed nationwide and Puerto
Rico.
Administration of this defective product could result in a
range of potential health effects that spans from temporary and medically
reversible to life threatening and death. There is significant concern that
health professionals who read the incorrect embossed concentration may upwardly
adjust the volume of product used resulting in an administered amount that is 5
times the recommended dose. In the hospital setting, the vials are often not
accompanied by the rest of the packaging, making it more likely that such a
dosing error could occur. Significant overdosing of a patient could lead to
signs and symptoms of albuterol toxicity, which includes tremors, dizziness,
nervousness, headache, seizures, angina, high blood pressure, low potassium
levels, and rapid heart rates up to 200 beats/minute.
The Ritedose Corporation is working cooperatively with the
U.S. FDA to implement a nationwide recall as quickly and efficiently as
possible.
