Class II
Terminated
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
- Recall Initiated
- December 14, 2017
- Posted
- February 7, 2018
- Recall Number
- D-0242-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 45,008 units/90 capsules each unit
- Firm Location
- Ridgefield, CT, United States
Reason for Recall
Failed Stability Specifications
Distribution
Distributed nationwide
Lot / Code Info
Lot # 606478; Exp. 03/18
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