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.