FDA-Drug2018-02-07Class II
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
Boehringer Ingelheim Pharmaceuticals, Inc.
Hazard
Failed Stability Specifications
Sold states
Distributed nationwide
Affected count
45,008 units/90 capsules each unit
Manufactured in
900 Ridgebury Rd, Ridgefield, CT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0242-2018Don't want to check this manually?
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