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FDA Safety Alert Regarding Mislabeled Albuterol Sulfate Inhalation Solution
Food and Drug Administration (FDA) issued a safety alert notifying the public that 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. 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. 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 five 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.
Affected lot numbers are manufactured by the Ritedose Corporation under NDC 0591-3797-83, 0591-3797-30, and 0591-3797-60. The lot numbers included in the recall are:
- 0N81, 0N82, 0N83, 0N84
- 0NE7, 0NE8, 0NE9
- 0NF0
- 0P12, 0P13, 0P46, 0P47, 0PF0
- 0S15
FDA advised consumers to immediately return affected product to the place it was obtained (ie, doctor’s office, pharmacy, etc). Wholesalers and retailers should return the product to the address stated in the Ritedose Corporation press release. FDA also encourages health care providers and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
