Drug recall D-0242-2018
Product
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
Reason for recall
Failed Stability Specifications
Lots and codes
Lot # 606478; Exp. 03/18
Recall details
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
- Quantity
- 45,008 units/90 capsules each unit
- Distribution
- Distributed nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 14, 2017
- Terminated
- October 17, 2018
Related products
- Spiriva – drug information
- NDC 0597-0075 Spiriva HandiHaler · Tiotropium Bromide Monohydrate 18 ug/1 · Boehringer Ingelheim Pharmaceuticals, Inc.