Boehringer Ingelheim Recalls Spiriva HandiHaler Due to Defective Delivery System
Boehringer Ingelheim is recalling Spiriva HandiHaler capsules because a defective delivery system may cause dose delivery out of specification.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Boehringer Ingelheim Roxane Inc is recalling Spiriva HandiHaler (tiotropium bromide inhalation powder) capsules. The recall involves 1,276,710 blister cards distributed nationwide and in Puerto Rico. The affected products are 18 mcg capsules in 5-count and 30-count blister cards with specific lot codes and expiration dates ranging from September to December 2014.
The recall was initiated due to a defective delivery system. There is a potential for dose delivery to be out of specification because of the interaction between the drug product powder and the lubricant on the interior of the capsule shell. This issue may affect the amount of medication delivered to the patient.
Patients and healthcare providers should stop using the affected Spiriva HandiHaler capsules and contact their healthcare provider for further instructions. The recall is classified as Class III by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- SPIRIVA (TIOTROPIUM BROMIDE)
- Brand
- SPIRIVA
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Category
- Drug — Inhalation Powder
- Hazard
- Affected units
- 1,276,710
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- a) 5 count capsule blister card: 303012A
- Exp Sep 2014
- b) 30 count capsules blister card: 303012B
- 303125A
- 303253A
- Exp Oct 2014
- 303895A
- 304282A
- Exp Nov 2014
- 304510A
- Exp Dec 2014
Distribution
Related recalls
Same brand · SPIRIVA
- ModeratePrescription drug SPIRIVA recalled for temperature storage deviation
FDA (Drugs) · 2024-01-03
- ModerateCardinal Health Recalls Spiriva Inhalers Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateBoehringer Ingelheim Recalls SPIRIVA HandiHaler Due to Failed Stability Specifications
FDA (Drugs) · 2018-02-07
- ModerateBoehringer Ingelheim Recalls SPIRIVA HandiHaler Due to Foreign Particles
FDA (Drugs) · 2013-09-25
Same manufacturer · Boehringer Ingelheim Roxane Inc
See all →- ModerateBoehringer Ingelheim Roxane Recalls Furosemide Tablets Due to CGMP Deviations
FDA (Drugs) · 2015-10-21
- ModerateBoehringer Ingelheim Roxane Recalls Furosemide Tablets Due to Manufacturing Error
FDA (Drugs) · 2015-10-21
- ModerateBoehringer Ingelheim Recalls Defective Combivent Respimat Inhalers
FDA (Drugs) · 2015-08-05
- ModerateBoehringer Ingelheim Roxane Recalls Subpotent Acarbose Tablets
FDA (Drugs) · 2015-06-03
- LowOxycodone Hydrochloride Oral Solution Recalled for Stability Failure
FDA (Drugs) · 2014-08-06