Drug recall D-0197-2024

Class II Terminated reported Jan 3, 2024

Product

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

Reason for recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Lots and codes

Batch 104440

Recall details

Recalling firm
CARDINAL HEALTHCARE, Dublin, OH
Quantity
5 units
Distribution
Nationwide USA
Type
Voluntary: Firm initiated
Recall initiated
January 26, 2022
Terminated
September 29, 2024

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