FDA-Drug2024-01-03Class II
SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41
CARDINAL HEALTHCARE
Hazard
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Sold states
Nationwide USA
Affected count
5 units
Manufactured in
7200 Cardinal Pl W, Dublin, OH, United States
Products
SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0197-2024Don't want to check this manually?
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