Alerts
Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall - Mislabeled Unit Dose Vials
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 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.
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.
The product is packaged as a single use unit dose vials in a protective foil overwrap packaged in a shelf carton. 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 should immediately return the affected product to the place it was obtained (ie, doctor’s office, pharmacy, etc.).
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