ALERT: FDA Initiates Albuterol Recall Over Mislabeling

January 5, 2011

Huge thank you to Barb Zahn, SMA mom, for sharing this…

ALERT: FDA Initiates Albuterol Recall Over Mislabeling

DrugAlert.org | January 5, 2011

A report released by the FDA on Monday announced the recall of mislabeled vials of Albuterol Sulfate Inhalation Solution.  The single-use, 2.5 mg/3 mL vials, produced by the Ritedose Corporation, “are embossed with the wrong concentration of 0.5 mg/3 mL and therefore, represents [sic] a potential significant health hazard,” says the FDA.

Though the foil overwrap pouches and shelf cartons display the correct concentration of the drug, the vials themselves bear incorrect labels which may lead doctors to mistakenly administer “5 times the recommended dose,” the report warns.  Because the outer layers of packaging are often removed when the vials are stocked in a hospital, the FDA claims it is likely that dosing errors could occur in this setting.

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