February 07, 2018
Boehringer Ingelheim Pharmaceuticals Inc. is recalling 1 lot of Spiriva HandiHaler (tiotropium bromide inhalation powder) 18-mcg capsules because the product failed to meet stability specifications, according to the February 7, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall spans 45,008 units, each containing 90 capsules, from lot 606478, which has an expiration date of March 2018. Cartons from the lot were distributed across the United States.
Boehringer Ingelheim Pharmaceuticals initiated the recall December 14, 2017. On January 26, 2018, the FDA designated the recall Class II. The classification indicates use of the drug could cause a temporary health problem, but serious harm is not likely.
Spiriva HandiHaler is a once-daily prescription maintenance medicine used long term to control symptoms of chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
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