The Ritedose Corporation has recalled some single-dose vials of albuterol sulfate inhalation solution, because an incorrect label could lead to an overdose.
In its recall announcement through the Food & Drug Administration, the company said the recall affects the 0.083% Albuterol Sulfate Solution because the 2.5mg/3ml vials are mismarked as containing 0.5/3ml.
If someone misreads the concentratiom, it could result in administering a dose that's 5 times what is intended.
Symptoms of an albuterol overdose include tremors, dizziness, nervousness, headache, seizures, angina, high blood pressure, low potassium levels, and rapid heart rates. It can potentially lead to death.
The recalled solutuion is conmtained in single-use vials in a protective foil wrap, packaged in a shelf carton. The correct concentration is on the primary foil overwrap pouches and shelf cartons. However, in the hospital setting, the vials are often not accompanied by the rest of the packaging. So users may not be aware of the labeling error.
The recalled lot numbers are sold under the NDC: 0591-3797, 0591-3797-30, and 0591-3797-60.
The lot numbers include:
0N81
0N82
0N83
0N84
0NE7
0NE8
0NE9
0NF0
0P12
0P13
0P46
0P47
0PF0
0S15
Consumers should return the product to the place where it was obtained.
Anyone needing more information can contact the company at 803-935-3995, Monday through Friday, from 8am to 5pm, or send an e-mail to recall@ritedose.com.
