The Food and Drug Administration is also concerned that hospital, med-center and emergency patients may be given the higher dose, as correctly labeled outer packaging is generally discarded.
Health care providers seeing only the mislabeled bottle would be very likely to give the wrong dose, especially since the two solution strengths are distilled in equal sized bottles. The .05 mg/3 ml bottles look just like the 2.5 mg./ 3 ml bottles. Only the strength differs.
Albuterol Sulfate Inhalation is sold in single use dosage bottles, in 25, 30 and 60 count unit dose packages. Recalled Albuterol was sold nationwide in the United States and in Puerto Rico.
Symptoms of over-dosing with Albuterol, known as albuterol toxicity, include headaches, nervousness, dizziness, seizures, high blood pressure, low potassium, angina and increased heart rates to 200 beats per minute.
Albuterol users and parents of children using an Albuterol nebulizer should return all Albuterol Sulfate Inhalation solution with product code numbers listed below to Ritedose.
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.
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