Albuterol Sulfate Recall: Asthma Drug Vials Have Wrong Dose Information

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The FDA is warning that dose vials of albuterol distributed by Ritedose are mislabeled and may contain five times the amount of the drug printed on the vials, which could lead to a drug overdose in asthma patients. 

A Ritedose albuterol recall and safety alert was announced on Monday by the FDA after it was discovered that vials containing 2.5 mg/3 mL were mislabeled as only containing 0.5 mg/3 mL.

The FDA said that the mislabeling represents a “potential significant health hazard” and warned that an overdose could cause albuterol toxicity, which can result in tremors, dizziness, nervousness, headaches, seizures, angina, high blood pressure, low potassium, heart rates of up to 200 beats per minute, and death.

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The mislabeling only occurs on the vials themselves, which are used in nebulizers. The packaging has the correct dosage information. However, there is increased concern about the use of Ritedose albuterol in hospital settings, where the dose vials may be removed from the packaging well before use.

Healthcare professionals in those settings may never see or handle the packaging with the correct dosage information. As a result, they may believe they need to increase the dosage of albuterol being given to the asthma patients, accidentally overdosing them. 

The recall affects 0.083% Albuterol Sulfate Inhalation Solution, 3 mL by Ritedose Corporation in 25, 30, and 60 unit dose vials. The recalled vials have an NDC of 0591-3797-83, 0591-3797-30, and 0591-3797-60; and include the following lot numbers: 0N81, 0N82, 0N83, 0N84, 0NE7, 0NE8, 0NE9, 0NF0, 0P12, 0P13, 0P46, 0P47, 0PF0, and 0S15. They were distributed throughout the U.S. and Puerto Rico.

The vials were shipped wrapped in foil and in cartons. The cartons and foil wrap have the correct dosage of 2.5 mg/3 mL. The Ritedose albuterol doses are prescription inhalation solutions used for the treatment and maintenance of acute asthma. Consumers are urged to immediately return any recalled Ritedose albuterol to the place of purchase or to where it was obtained.

Asthma affects 20 million Americans, including 6.5 million children. It is a chronic disease with symptoms like wheezing, difficulty breathing and spasms, which can severely limit activities and impact quality of life.

Tags: Asthma, Asthma Drug, Drug Recall, Nebulizer, Overdose

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7 Comments

  1. monica

    I refilled my sons prescription at Walmart and the pharmacists wrote the wrong dosage. It was a dosage that was was enough for 3 full days. I was ferrous!!! If I would have given this to a care taker with out looking my son could have died! As a parent it is my job to check as I did, but should the pharmacist as well?

  2. Monica G.

    I worked for a Wal-Mart pharmacy as a technician for 5 years. The store I worked for was WONDERFUL! Wal-Mart uses a computer system called Connexus to fill prescriptions. With Connexus, a technician takes in your prescription, fills in the information from the written prescription & scans the written prescription to the computer. From there, an RPh (Registered Pharmacist) “4-Points” the prescription by comparing what the technician has entered to what the doctor has written on the physical prescription. That RPh then releases that order (if all is correct OR makes corrections if necessary) for a technician to fill. The order then goes to a hand-held computer, & a technician fills the prescription. Once that order is finished, another RPh checks the written prescription again & compares the medication in the bottle to the picture of the medication that is on his/her screen. He/she also checks to make sure that the dosage, amount, & directions for taking/using is correct. Accidents happen, we’re only human.

    BUT… When my husband transferred to another state with his job, I transferred to a different Wal-Mart. The pharmacy I transferred to was sloppy, haphazard & negligent in their work habits. If things were busy, the RPh would let a “seasoned” technician do the initial entering AND 4-Pointing; meaning that the same eyes that had entered that prescription (perhaps incorrectly) were now okaying that prescription for filling. Only an RPh is supposed to 4-Point. In some states it is permissible for a technician to take an order, by phone, from a doctor’s office. That’s a practice I find unacceptable, but there you have it.

    After a few months of working with a pharmacy crew I found to be sub-standard, I quit. If I didn’t know my medications, dosage amounts & usages, I would most likely not have prescriptions filled at a Wal-Mart pharmacy.

  3. RODNEY

    TOOK THE OVERDOSE FOR 27 DAYS. THINK IT DAMAGED MY LUNGS.

  4. RODNEY

    I went to my family doctor with a bad cold,she prescribed cough syrup and albteroul for my symptoms. I usede as pescriped but my shortness of breath kept getting worse. not better, after I got the notice to stop using I had already used 27 doses

  5. Amy

    My father was prescribed Abuterol for his lungs. He used it in a nebulizer. He had very seious side effects such as hallucinations, imagining that people were in the room, could not breathe correctly, severe dry mouth, ringing in the ears, yelling out in his sleep, one eyeball was popping out while the other eye was swelled shut, incapable of eating, nervousness and very restless. My father is 82years old and it scared the shit out of his children. We thought he had gone nuts and we needed to committ him or send him to the hospital. It was very scary and I think this drug is dangerous.
    We are afraid he may have brain damage because his speech is impaired and he can’t talk correctly.

  6. Kimberly

    Ive been having problems since i refilled my albuyerol script. It is a fluke i ended up on this site,i had received a new neb machine and thought it was the cause of my increased breathing issues. Well i looked at my box & vials of albuterol & their on the recal list. Ive been having chest pain ,high blood pressure which ive never had ,lots of heart palpitations,and more wheezing,ringing in my ears, and unable to function normaly. I had no clue it was my albuterol causeing it,i feel more shaky & agitated as well as panic attacks & wheezing more. What do i do now

  7. Linda

    My husband took this medication and since then he has had really bad breathing problems he does have COPD but I think this really pushed him over the edge he had pneumonia four or five times since then they diagnosed him with COP cryptogenic organizing pneumonia

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