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Boehringer Ingelheim Pharmaceuticals, Inc. recalls SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx

Recalled February 7, 2018 · FDA recall D-0242-2018 · Boehringer Ingelheim Pharmaceuticals

Hazard
Failed Stability Specifications · FDA Class II
Units
45,008 units/90 capsules each unit
Sold at
Distributed nationwide

Description

Failed Stability Specifications

Product
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47
Manufacturer(s)
Boehringer Ingelheim Pharmaceuticals, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Boehringer Ingelheim Pharmaceuticals, Inc. recalls SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx | RecallWatchUSA