Drug 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
D-0242-2018
Product summary
- Event
- Event 78775
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45,008 units/90 capsules each unit
- Official record key
drug-enforcement:D-0242-2018
Official wording
Reason: Failed Stability Specifications
Code information: Lot # 606478; Exp. 03/18
Distribution pattern: Distributed nationwide
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications