Spiriva Handihaler Capsule Recall Issued Due to Foreign Particles

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Irvin Jackson

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More than 15 million Spiriva Handihaler capsules have been recalled due to concerns that they may be contaminated with foreign particles.  

The Spiriva recall was announced in an FDA weekly enforcement report on September 25, indicating that there is a potential for extrinsic foreign particles in the API used to manufacture the Spiriva Handihaler.

There have been no injuries or illnesses associated with the recall, and the action has been categorized as a Class III recall, meaning that the FDA believes there is little health threat for consumers.

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The recall affects an estimated 15,385,232 Spiriva Handihaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, distributed in 10 count blisters with NDC 0597-0075-27, 30-count blisters with NDC 0597-0075-41, 90-count blisters with NDC 0597-0075-47, and 5-count blister physician samples with NDC 0597-0075-75. The Spiriva Handihaler capsules were manufactured by Boehringer Ingelheim.

Spiriva (tiotropium) is a medication used for the long-term maintenance treatment of bronchospasm linked to chronic pulmonary obstructive disease (COPD). Since the Handihaler was approved by the FDA in 2004, it has grown to dominate the market for COPD inhalers and has been used by millions of Americans.

Concerns about heart problems with Spiriva have been raised in connection with the Handihaler, following a previous combined analysis of 29 clinical trials, which found that users may face a slight increase in the risk of stroke when compared to the use of a placebo. In October 2008, a subsequent study showed that users of Spiriva Handihaler may face an increased risk of heart attack, stroke and death.

The FDA conducted a Spiriva safety investigation in 2010, but did not find a link between the inhaler and an increased risk of heart attack, stroke or death.

Irvin Jackson
Written by: Irvin Jackson

Senior Legal Journalist & Contributing Editor

Irvin Jackson is a senior investigative reporter at AboutLawsuits.com with more than 30 years of experience covering mass tort litigation, environmental policy, and consumer safety. He previously served as Associate Editor at Inside the EPA and contributes original reporting on product liability lawsuits, regulatory failures, and nationwide litigation trends.

Tags: Boehringer Ingelheim, COPD, Heart Attack, Spiriva, Stroke
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11 Comments

Lori
I think you need to take more care in your QA. The price you charge for this medication is getting out of hand. However, my concern is the way you are cheating your customers. Just about every box of Spiriva I am getting lately is having empty spaces. There are no caplets in you sheets of medicine. I feel you should have a little more effort in making sure people are getting the needed doses they are paying for. Shame on you.
David
I have been using Spiriva for bout two n half years I see halos around light and vision is blurry I get sick often now I just recently switched to something else I was told it wasn’t the cause I had stomach pains when using n chest pain since changing it isn’t as bad but still there but vision is still blurry n still seeing lights the chest pain has slacked some but still there I am afraid I have done permanent damage using this medication.should be recalled and taken Off market
brian
the plastic capsules break up infect throat nose, brancs. i been using straw and bad pain subside but dr said no.
A
I was on sprivia. Used it for two weeks. Spent a night in emergency. Heart problems. Severe cheat pain. I stopped using it. Three days later. Feeling alot better. This is a bad drug
Mary
My father was prescribed Spiriva in February 2015. He had severe stomach aches whenever he used it. He was diagnosed with Pancreatic cancer in July. He was 81. He never smoked or had any family history of cancer. He went for chemo treatments in August with no other options given to him. Before the chemo he had bleeding ulcers, UTI’s and heart problems. Before taking Spiriva all he ever had was chronic bronchitis. He passed away last October of pneumonia and septic shock. I know there is no proof that Spiriva may of caused all of his problems, but I watched him develop all this after using it.
Bonnie
Alfred Trigger, my husband, started using Spiriva in July 2014. Within 2 weeks he began coughing up blood. In Oct. 2014 his doctor said he was good for 1 year followup. Dec.2015 he with to the doctor because he thought he had a cold. Dec.31, 2014 he went in the hospital for a biopsy and died 22 days later. The night before the biopsy he said “If anything happens to me tell them it was the Spiriva.” He got pneumonia 2 days after the biopsy. he never got the chance to try any further medical help. This drug needs MUCH more looking into before it is prescribed to ANYONE.
Kimberly
My mom died from Aspiratic pneumonia after surgery. She was in the hospital for months. And died shortly after surgery for no aparent reason. After using spireva for 4 years she had no heart condition or anything else that could have led to het death.
pattie
My husband has been on and off this medicine for sometime now . We currently have a few boxes of 30 day dose and from the lot number being recalled He currently has a lot of trouble with blotting and every bone and measle in his body hurts. He is tired all the time. Was anyone else’s prescription filled at a VA hospital?
Barbara
taking the drug made me very tired and at time I could see light flashes. I was not made aware of this recall.
Deborah
I used Spiriva for 10 days on the 11th day I woke up to swollen toung with large red spots as well as large lips and swollen thoart I was also having difficulty walking and breathing .I did not use the inhaler that day and called my Doctor. after not hearing from anyone for three days I went to the hospital . most of the swelling was gone but I seamed to have delveloped a heart a problem. I was unable to take cemo .
julie
I had taken spiriva. after awhile I was having double vision. so I stopped the spiriva, but the double vision did not go away and my right eye seems droopy. I still havve a couple capsules from 0597-0075-41 which I now understand were recalled. I wish I never took this stuff. not sure what to do.

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