Boehringer Ingelheim Pharmaceuticals, Inc. recalls SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx…
- Recall date
- December 14, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0242-2018
- FDA classification
- Class II
- Brand / firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Sold / distributed
- Distributed nationwide
Why it was recalled
Failed Stability Specifications
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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