Cardinal Health Inc. recalls Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx
Recalled June 2, 2021 · FDA recall D-0453-2021 · Cardinal Health
Hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage. · FDA Class II
Units
2611 inhalers
Sold at
FL, GA, SC
Description
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product
Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 Manufactured by: Boehringer Ingelheim (BI) Pharma GmbH & Co. KG Ingelheim, Germany Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Pfizer, Inc. New York, NY 10017 USA
Manufacturer(s)
Cardinal Health Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →