** Albuterol Sulfate Inhalation Solution ** RECALL

Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall - Mislabeled Unit Dose Vials
[Posted 01/03/2011]

AUDIENCE: Family Practice, Pharmacy, Consumer

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. In the hospital setting, the vials are often not accompanied by the rest of the packaging, making it more likely that such a dosing error could occur. 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: This product is a prescription inhalation solution, administered via nebulization, for the treatment and maintenance of acute asthma exacerbations and exercise induced asthma in children and adults. The product is packaged as a single use unit dose vials in a protective foil overwrap packaged in a shelf carton. 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.). Wholesalers and retailers should return the product to the address stated in the firm Press Release.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


link to FDA

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

thank you for posting this....I just FREAKED out bc we filled our Albuterol script last week and was very relieved to see that the lot #'s weren't one of the recalled ones. However, I am so upset to read about yet another recall of children's medication.

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

Thanks for the post. I just checked ours and they weren't on the list, thankfully. But I totally agree with PP ... what's going on with all of these recalls of children's meds????

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

thank you for posting.

I just checked ours and its a diff number and manufacturer

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

ours arent on the list either but geez these recalls are popping up all of the time.

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

i have to check ours

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

whew, not ours. Thank god.

My heart just sunk as I signed on here bc I JUST finished giving my DS his nebulizer.

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

wow thanks for posting!
checking now!!

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

Thanks for posting!

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

Thanks for posting..my heart just sank...
Our ndc's are not affected thank god.

This just infuriates me to no end....what is going on in this country with childrens ( and adults ) medications? We pay endless amounts of money and things like this should NOT happen....ever....

I seriously am looking into how to support medication safety legislation/changes more because I just can't live in fear of the next mistake someone else makes. Ughh

Message edited 1/3/2011 9:54:28 PM.

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

omg these are mine! Gianluca was on this for 5 days about a week and a half ago..he was HORRENDOUS on it..like worse than typical "albuterol" symptoms (i know from my older ds)
holy crap..so what do i do now? can this still be harmful i wonder?
i seriously just got so upset

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

omg I have to check! Thanks for posting!!

oops never mind...my ped just prescribed the solution without the inhaler so this doesn't apply to us.

Message edited 1/4/2011 7:28:39 AM.

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

how is this a voluntary recall??????

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

Posted by TaraGotHutched

omg I have to check! Thanks for posting!!

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL

I just alerted my friend as my Godson has been getting treatments since they released him from the hospital. W the Effing Heck is going on with these friggin companies???????

Re: ** Albuterol Sulfate Inhalation Solution ** RECALL