FDA: Albuterol Sulfate Inhalation Solution Recalled

[CAT-CNA]

When are pharmacies notified of recalls? The article is dated Jan. 4 and I called Walgreens to ask about this product--my 6 yr old is on this (the one diagnosed with Tachycardia with heart murmur)--and the pharmacist told me he did not know/haven't heard about the recall. I have to wait until tomorrow the call her doc. cause she uses her nebulizer quite frequently.

[MunoRN, RN]

It was only "Ritedose" albuterol that was recalled, and even then it was only due to a dosage mislabeling, not something wrong with the drug itself (at least nothing more wrong with it than other racemic albuterol which should have been banned once we figured out how to isolate ®albuterol from (S) albuterol). While it's definitely unsafe to give a dose that is larger than you think it is, it's also interesting that the FDA states that the 2.5% dosage is potentially life threatening, although this is the standard neb dose we give in the hospital and you don't see the FDA doing anything to fix that.

[GreyGull]

munorn said:

It was only "ritedose" albuterol that was recalled, and even then it was only due to a dosage mislabeling, not something wrong with the drug itself (at least nothing more wrong with it than other racemic albuterol which should have been banned once we figured out how to isolate ®albuterol from (s) albuterol).

You must be a fan of Xopenex.

Albuterol sulfate is still the most common bronchodilator used in the u.s. let's not start a panic by saying albuterol should be banned. Some people depend on it to rescue them in an emergency.

munorn said:

While it's definitely unsafe to give a dose that is larger than you think it is, it's also interesting that the fda states that the 2.5% dosage is potentially life threatening, although this is the standard neb dose we give in the hospital and you don't see the fda doing anything to fix that.

The standard dose is 2.5 mg or a 0.083% solution (2.5 mg/3 ml) when in the vial or 0.5% in the undiluted form which is 2.5 mg/0.5 ml.

Duoneb, trade name of a common combination, contains 3.0 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base).

[CAT-CNA]

TY for the replies, I think maybe I freaked before I throughly read the article. The script my girl has is made bu Mylan. It does make you wonder how long it takes a pharmacy to become aware of recalls if the pharmacist did not know about it. Yes the article came out on the 4th but it also said that health care professionals and consumers were notified--I guess the pharmacy does not count.

[GreyGull]

The official notice from the FDA came out January 3. Ritedose did a press release for the voluntary recall 12/30/10.

Some of us are on the FDA email list but I may not always monitor my email all day if I am busy. If someone in the department who gets the FDA email is off that day, posting the notice might be a day late. There are some medical professionals who do get the email alerts themselves just to stay updated but the number of recalls and notices from the FDA can be numerous and some may opt for the weekly digest although probably not a pharmacy.

Some of us are on the FDA email list but I may not always monitor my email all day if I am busy. There are some medical professionals who do get the email alerts themselves just to stay updated but the number of recalls and notices from the FDA can be numerous and some may opt for the weekly digest although probably not a pharmacy.

We don't use this brand in the hospital or the Respiratory Therapists would have noticed right away if their standard 3 ml 7 minute nebulizer would now take over an hour with 15 ml of liquid to get the same dose. Those in home care who are familiar with the dosages on the package would also have been calling their pharmacist to ask how to squeeze that much liquid into an acorn neb and how long their supply would last it would take 5 vials to make one 2.5 mg treatment. But, chances are most in home care didn't notice and the correct dose was given regardless of the mislabeled package. This may also have applied to the hospitals, LTC facilities and EMS where those administering the meds just grab the package thinking it is business as usual or have never bothered to learn the dosing of respiratory meds since they come in those convenient single dose packs.