by Candace McNaughton, ND
Those of you on an Albuterol inhaler should check the dose and lot number marked on your medicine. There has been a recall due to mislabeling where the vials are actually five times the strength of what they are marked. Read details below and at the FDA site.
“Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall – Mislabeled Unit Dose Vials
[Posted 01/03/2011]
ISSUE: 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.
There is significant concern that health professionals who read the incorrect embossed concentration may upwardly adjust the volume of product used resulting in an administered amount that is 5 times the recommended dose. Significant overdosing of a patient could lead to signs and symptoms of albuterol toxicity, which includes tremors, dizziness, nervousness, headache, seizures, angina, high blood pressure, low potassium levels, and rapid heart rates up to 200 beats/minute.
BACKGROUND: 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.
RECOMMENDATION: Consumers should immediately return the affected product to the place it was obtained (i.e. doctor’s office, pharmacy, etc.).”
