Mislabeling of Unit Dose Vials Causes Albuterol Inhaler Recall

The Ritedose Corporation has announced a voluntary nationwide recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL (in 25, 30, and 60 unit dose vials) because of a prospective major health risk. According to the FDA recall press release, the prescription inhalers are used to treat acute asthma and exercise induced asthma in children and adults.

The inhalers are being removed from the market due to improper labeling. Apparently the 2.5 mg/3 mL single use vials are marked with the incorrect concentration of 0.5 mg/ 3 mL, affecting the dose taken by patients. The incorrect label of the single use inhalers is only on the unit dose vials themselves. However, the correct formulation of the inhalers is stated on the primary foil overwrap pouches and shelf carton packaging.

The inhaler concentration mislabeling could cause health professionals to incorrectly advise patients of how to use the medication, potentially resulting in use of up to 5 times the recommended dosage. The risk of dose error is even more significant in a hospital setting since the entire inhaler packaging (which has the correct information on it) usually does not accompany its vial.

Patient use of the defective inhalers could potentially cause serious health complications or death from overdose. Signs and symptoms of albuterol toxicity include but are not limited to tremors, dizziness, nervousness, headache, seizures, angina, high blood pressure, low potassium levels, and increased heart rates up to 200 beats per minute.

Consumers are being advised to discontinue use of the recalled inhalers and return them where they were obtained.

Drug manufacturers are responsible for designing and creating medications that are safe for the purpose intended, correctly labeled, tested properly, and free of any defects that could cause harm to a consumer. The New Jersey product liability attorneys at Blume Forte have extensive experience handling a wide range of defective product cases for individuals who have been injured and family members of those killed by product defects. Call our firm at 973-845-4421 for a no-cost consultation and to find out if you may have a viable claim.

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