Some vials of Albuterol, an inhalation solution prescribed to adults and children to treat wheezing and shortness of breath caused by breathing problems such as asthma, is being recalled by Ritedose Corporation because the vials are mislabeled with the wrong concentration of the active ingredient, posing a potentially dangerous health hazard to users.

The recall includes 0.083 % Albuterol Sulfate Inhalation Solution, 3 mL in 25-, 30- and 60-unit dose vials because the 2.5 mg/3 mL single use vials list a concentration of 0.5mg/3 mL. Only the unit dose vials are incorrectly embossed as containing 0.5 mg/3 mL. The correct concentration of 2.5/3 mL is labeled on the primary foil overwrap pouches and shelf cartons.

The primary concern is that health professionals who read the incorrect embossed concentration may upwardly adjust the volume of the product used resulting in an administered amount that is 5 times the recommended dose. In hospital settings, the vials are not usually accompanied by the rest of the packaging, making it more likely that such a dosing error would 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 of up to 200 beats per minute.

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. This product was distributed nationwide and Puerto Rico.

Consumers who have the recalled product should immediately return it to the doctor’s office or pharmacy where it was obtained. Any side effects with this or any other drug should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.