Recalls / Class II
Class IID-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
- Brand name
- Spiriva
- Generic name
- Tiotropium Bromide
- Active ingredient
- Tiotropium Bromide Monohydrate
- Route
- Oral, Respiratory (inhalation)
- NDC
- 0597-0075
- FDA application
- NDA021395
- Affected lot / code info
- Lot # 606478; Exp. 03/18
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 900 Ridgebury Rd, Ridgefield, Connecticut 06877-1058
Distribution
- Quantity
- 45,008 units/90 capsules each unit
- Distribution pattern
- Distributed nationwide
Timeline
- Recall initiated
- 2017-12-14
- FDA classified
- 2018-01-26
- Posted by FDA
- 2018-02-07
- Terminated
- 2018-10-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0242-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.