FDA: Albuterol Sulfate Inhalation Solution Recalled

Ritedose issues voluntary recall due to wrong concentration embossed on vials

TUESDAY, Jan. 4 (HealthDay News) -- The U.S. Food and Drug Administration and The Ritedose Corporation have notified health care professionals and consumers of a voluntary recall of 0.083 percent Albuterol Sulfate Inhalation Solution, 3 mL in 25, 30, and 60 unit dose vials, as the 2.5 mg/3 mL single use vials are embossed with the incorrect concentration of 0.5 mg/3 mL. This may pose a health risk to patients, which could result in temporary and medically reversible events or even life-threatening events and death.

The correct concentration of 2.5 mg/3 mL is labeled on the primary foil overwrap pouches and shelf cartons; however, the unit dose vials are incorrectly embossed as containing 0.5 mg/3 mL. The company issued the recall because health professionals who read the incorrect embossed concentration may increase the volume of the product used, which would result in an administered amount that is five times the recommended dose. The concern is even greater in the hospital setting, where the vials are often not accompanied by the rest of the packaging.

Albuterol Sulfate Inhalation Solution, administered using nebulization, is indicated for the treatment and maintenance of acute asthma exacerbations and exercise induced asthma in children and adults. The lots included in the recall were distributed nationwide and in Puerto Rico. No other albuterol formulations or products are included in the recall.

According to the FDA, "consumers should immediately return the affected product to the place it was obtained (i.e., doctor's office, pharmacy, etc.)." They added that wholesalers and retailers should return the product to the address stated in the firm press release.

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